Addiction rewires the brain on a genetic level. As we learn more, new avenues for treatment come into focus

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Many people are wired to seek and respond to rewards. Your brain interprets food as rewarding when you are hungry and water as rewarding when you are thirsty. But addictive substances like alcohol and drugs of abuse can overwhelm the natural reward pathways in your brain, resulting in intolerable cravings and reduced impulse control.

A popular misconception is that addiction is a result of low willpower. But an explosion of knowledge and technology in the field of molecular genetics has changed our basic understanding of addiction drastically over the past decade. The general consensus among scientists and health care professionals is that there is a strong neurobiological and genetic basis for addiction.

As a behavioral neurogeneticist leading a team investigating the molecular mechanisms of addiction, I combine neuroscience with genetics to understand how alcohol and drugs influence the brain. In the past decade, I have seen changes in our understanding of the molecular mechanisms of addiction, largely due to a better understanding of how genes are dynamically regulated in the brain. New ways of thinking about how addictions form have the potential to change how we approach treatment.

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Alcohol and drugs affect brain gene activity

Each of your brain cells has your genetic code stored in long strands of DNA. For all that DNA to fit into a cell, it needs to be packed tightly. This is achieved by winding the DNA around “spools” of protein called histones. Areas where DNA is unwound contain active genes coding for proteins that serve important functions within the cell.

When gene activity changes, the proteins your cells produce also change. Such changes can range from a single neuronal connection in your brain to how you behave. This genetic choreography suggests that while your genes affect how your brain develops, which genes are turned on or off when you are learning new things is dynamic and adapts to suit your daily needs.

Recent data from animal models suggests that alcohol and drugs of abuse directly influence changes in gene expression in areas of the brain that help drive memory and reward responses.

Within each neuron in the brain, how tightly DNA is wound around or bound to histones and other proteins determines which genes are expressed and which proteins are produced.
Within each neuron in the brain, how tightly DNA is wound around or bound to histones and other proteins determines which genes are expressed and which proteins are produced. Karla Kaun and Vinald Francis, CC BY-ND

There are many ways addictive substances can change gene expression. They can alter which proteins bind to DNA to turn genes on and off and which segments of DNA are unwound. They can change the process of how DNA is read and translated into proteins, as well as alter the proteins that determine how cells use energy to function.

For example, alcohol can cause an alternative form of a gene to be expressed in the memory circuits in flies and people, resulting in changes in dopamine receptors and transcription factors involved in reward signaling and neuronal function. Similarly, cocaine can cause an alternative form of a gene to be expressed in the reward centers of mice, leading them to seek out more cocaine.

Exactly how these drugs cause changes in gene regulation is unknown. However, a direct link between alcohol consumption and changes in gene expression in mice provides a clue. A byproduct of alcohol being broken down in the liver called acetate can cross the blood-brain barrier and unwind DNA from histones in mouse memory circuits.

Alcohol, nicotine, cocaine and opioids also all activate important signaling pathways that are central regulators of metabolism. This suggests they can also affect many aspects of neuronal function and consequently affect which genes are expressed.

Changing brain gene activity with lifestyle

How addictive substances change cell function is complex. The version of a gene you’re born with can be modified in many ways before it becomes a functional protein, including exposure to alcohol and drugs. Rather than discouraging researchers, this complexity is empowering because it provides evidence that changes to gene expression in your brain aren’t permanent. They can also be altered by medications and lifestyle choices.

Many commonly prescribed medications for mental health disorders also affect gene expression. Antidepressants and mood stabilizers can change how DNA is modified and which genes are expressed. For example, a commonly prescribed drug for depression called escitalopram affects how tightly wound DNA is and can change the expression of genes important to brain plasticity.

Additionally, mRNA-based therapies can specifically change which genes are expressed to treat diseases like cancer. In the future, we may discover similar therapies for alcohol and substance use disorder. These treatments could potentially target important signaling pathways linked to addiction, altering how brain circuits function and how alcohol and drugs affect them.

Lifestyle choices can also affect gene expression in your brain, though researchers don’t yet know whether they can alter the changes induced by addictive substances.

Like alcohol and drugs, dietary changes can affect gene expression in many ways. In flies, a high sugar diet can reprogram the ability to taste sweetness by tapping into a gene expression network involved in development.

Intensive meditation, even after only one day, can also affect gene regulation in your brain through similar mechanisms. Attending a monthlong meditation retreat reduces the expression of genes that affect inflammation, and experienced meditators can reduce inflammatory genes after just one day of intensive meditation.

Work in animal models has also shown that exercise changes gene expression by altering both histones and the molecular tags directly attached to DNA. This increases the activity of genes important to the activity and plasticity of neurons, supporting the idea that exercise improves learning and memory and can decrease the risk of dementia.

From Dry January and beyond, many factors can have profound effects on your brain biology. Taking steps to reduce consumption of alcohol and drugs and picking up healthy lifestyle practices can help stabilize and bring long-lasting benefits for your physical and mental health.

Karla Kaun is an Associate Professor of Neuroscience at Brown University. Follow Karla on Twitter @karlakaun

A version of this article was originally posted at The Conversation and has been reposted here with permission. Any reposting should credit the original author and provide links to both the GLP and the original article. Find The Conversation on Twitter @ConversationUS

Viewpoint: Does Donald Trump’s authoritarian style and his popularity among ultra-conservative religious leaders echo the rise of Hitler’s Nazi Germany?

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Each September marks the anniversary of Nazi Germany’s Nuremberg Laws, whose passage in 1935 stripped Jews of their German citizenship and banned “race-mixing” between Jews and other Germans.

Eighty-eight years later, the United States is facing rising antisemitism and white supremacist ideology – including two neo-Nazi demonstrations in Florida in September 2023 alone.

The Nuremberg Laws were a critical juncture on the Third Reich’s path toward bringing about “the full-scale creation of a racist state … on the road to the Holocaust,” according to legal historian James Whitman. Yet across the Atlantic, many Americans were unconcerned, and even admiring – including some religious leaders.

As a political scientist and a sociologist, we wanted to examine what Americans thought about Hitler and the National Socialist Party before the U.S. entered World War II – and see what lessons those findings might hold for our country today. Our recent research, which focused on religious publications, suggests that Americans’ support for Nazi Germany is best explained by belief in white supremacy.

View from the pulpit

In 1935, Adolf Hitler entered his third year in power and legally solidified the Nazi regime’s racist policies. During this period, Jews, Romani, homosexuals, the mentally or physically disabled and African-Germans were all targets of Hitler’s wrath. Thousands of refugees fled the country in search of safety – many to U.S. shores.

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Chart from Nazi Germany showing the regime’s racial categorizations under the Nuremberg Laws of 1935.

Individual public opinion data about Nazi Germany is not available for this period; Gallup’s first survey on the topic was conducted in 1938. Instead, we used a database of periodicals from religious organizations that one of us, Wilde, had originally compiled for a book on views of contraception in the early 20th century. Using these periodicals, we examined the views of leaders in 25 of the United States’ most prominent religious groups.

In the 1930s, the U.S. was a far more religious country than it is today, with around 95% of Americans claiming membership in a religious denomination. The groups in our sample include 82% of Americans who reported religious membership at the time. Most are white Protestant denominations, but our sample also included Roman Catholics, three Jewish groups, Black churches, and smaller groups like Jehovah’s Witnesses and the Church of Jesus Christ of Latter-day Saints.

We argue that while these texts are not necessarily representative of individual members’ views, they are evidence of the views religious elites tried to cultivate in large segments of the American population.

‘Unequaled in cruelty’

These periodicals dispel the notion that Americans did not know, or understand, the gravity of the situation in Germany at the time. A third of the denominations in our sample were critical of Hitler, and their alarm demonstrates that ample information was available about the escalating situation in Nazi Germany.

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A poster designed by Jean Carlu for Fortune magazine in 1941.

These groups, which were both Christian and Jewish, wrote about “the omnipresent terror that grips every town and hamlet”; the German concentration or “education camps”; and the number of people jailed, sent to camps, killed or sterilized. Leaders of Conservative Judaism warned that “German Jewry is on the way to extinction.” The Universalist General Convention described the situation in Germany as “unequaled in cruelty and brutality even by the Spanish Inquisition.”

On the other end of the spectrum, religious leaders from the Norwegian Lutheran Church, which has long since merged with other denominations, emphasized that Hitler was legitimately elected and enjoyed strong support among the German people. Another article recounted a recent trip to Germany, writing that “what we interpret as militarism” is a manifestation of support for “the program of Hitler” and “the common good.” The Presbyterian Church in the U.S. – a white Southern denomination that later merged with other Presbyterian denominations – wrote of Hitler’s regime making “effort[s] toward social justice” with reforms for illegitimate children.

And while some religious elites sympathetic to Hitler acknowledged that the Nazis’ tactics were unsavory, they suggested “the means do not, taken by themselves, condemn the end.”

Finding the pattern

As we analyzed the periodicals, we classified leaders’ writings into four categories. Beyond groups that clearly sympathized with Hitler or criticized him, the largest number were ambivalent, with mixed views. Others were “distant,” barely commenting on events in Europe.

We found that two main factors explain religious elites’ views of Hitler in 1935. The first is whether their group embraced white supremacist ideas. The second is whether they were atop the religious hierarchy – that is, mainstream Protestant denominations whose members would not have been at risk of persecution in Germany.

Groups that consistently criticized Hitler had members that were marginalized because of their race or ethnicity. They regularly spoke out against prejudice, segregation and lynching. In contrast, denominations that were well established and mostly white tended to be ambivalent toward Nazism, even those that spoke out against anti-Black racism in the U.S.

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Jewish pushcart workers on New York’s Lower East Side participated in a two-hour protest in 1933, refusing to make sales, during a day of mass demonstrations against the persecution of German Jews.

But a few groups, five in total, did more than express ambivalence – they openly sympathized with Hitler. What united these groups were white supremacist beliefs. Their periodicals included articles titled “The Fitness of the Anglo-Saxon” and “Why the Anglo Saxon,” emphasizing “men are born equal in their rights, but they are not equal in their fitness and ability to serve … God needed the white Anglo-Saxon race.”

Importantly, the groups that supported Hitler were also antisemitic and eugenicists, believing human beings could be “perfected” through selective breeding.

However, antisemitism was rampant at the time, even among groups that were ambivalent about Hitler. Similarly, support for eugenics was too broad to explain why certain religious groups in the U.S. sympathized with the Nazis. There were even religious leaders who criticized Hitler yet had connections to the American Eugenics Movement, which promoted forced sterilization laws and, later, the legalization of birth control.

Instead, what most strongly differentiated Hitler’s sympathizers in this era was their belief in white supremacy vis-a-vis African Americans. These groups published literature claiming that African Americans were physically and mentally inferior, and one wrote positively of the Ku Klux Klan. A Southern Baptist bishop wrote, “The Negro is not like the white man … there are striking differences physical and mental,” going on to claim, “the white race … assumes its superiority in strength and capacity.”

Fast-forward

Although 1935 is nearly a century behind us, U.S. politics has been awash in comparisons to the Third Reich for several years now. Former President Donald Trump recently compared his indictments to Nazi Germany, obfuscating the mass atrocities of Hitler’s regime.

But such comparisons do prompt reflection on what drove American support for Nazi Germany in the 1930s, as Trump campaigns with an authoritarian vision for his second term, and as white nationalism remains a major aspect of U.S. politics.

In 1935, Europe was not at war, and concern about mass killings would have seemed alarmist. Yet just a few years later, a global conflagration began. On the anniversary of the Nuremberg Laws, what motivated American support for Hitler’s authoritarianism in the 1930s still resonates today.

Meghan Garrity is an Assistant Professor of International Security & Law at George Mason University. Find Meghan on X @mmgarrity

Melissa J. Wilde is Professor and Chair of Sociology at the University of Pennsylvania. 

A version of this article was originally posted at the Conversation and is reposted here with permission. Any reposting should credit both the GLP and original article. The Conversation can be found on X @ConversationUS

Viewpoint: Are organizations claimed as “partners” with tort industry-funded Heartland Study aware of the scam? Here’s an ‘open letter’ challenge

dark money funded by organic farming companies and litigators
Multiple science communicators and scientists have composed a letter to various universities and government organizations that have been linked to the Heartland Health Research Alliance. HHRA is a front that delivers studies-on-order on the dangers of chemicals for clients, including large organic companies tied to litigator groups and individual stort lawyers who provide much of the funding for its “Heartland Study”. Most of the money is hidden from scrutiny by pass-throughs from donor funds, traditionally money as ‘dark money’ funding. Here is one of many reports that Genetic Literacy Project has done on the Heartland Study.

TO: Boston College, George Mason University, George Washington University, Gunderson Health Systems, Indiana University College of Medicine, Kings College London, Simon Fraiser University, University of Iowa Health, The Centre de Toxicologie du Québec, Minister of Health and Social Services, and U.S. Centers for Disease Control

We are writing to express concern regarding recent reports regarding public representations of your institution’s “partnership” role participating in human subject matter research and related projects coordinated and funded by the Heartland Health Research Alliance.[1] According to several reports, the so-called Heartland Study is a front group financed by class action litigators and organic food industry marketing interests who plan to profit from their activities.

The Heartland Study has listed your organization as a formal partner in this scheme for both fundraising and public relations purposes to enhance their credibility. The Heartland Study founder and executive director Charles Benbrook has a well-documented history of offering “pay to play” research with pre-determined outcomes for his consulting clients in the organic food marketing and mass tort litigation industries. In fact, he was terminated from his most recent academic appointment after failing to disclose conflicts of interest and funding sources for his work.

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In addition, Heartland’s founding board members include representatives from class action litigators and organic industry marketers directly involved in lawsuits and campaigns linked to the so-called study’s predetermined plans to correlate negative child and maternal health outcomes with GMO and herbicide exposure. Conveniently, these board members and Heartland funders are also Benbrook’s business partners and clients who, according to various public court documents, have paid him and his family members hundreds of thousands of dollars for these services while also providing the seed and ongoing operational financing for the Heartland Study.

To date, several articles have been published by researchers using their positions with your named institutions while being paid by Heartland without fully disclosing their affiliations with this group, funding they received from Heartland donors, or the funders’ ties to competing interests. Further, several Heartland-funded researchers are involved in this research without disclosing these conflicted funding sources and competing interests to the human subjects they are enlisting to participate.

These types of activities are potential serious violations of academic ethics and compliance standards and are an affront to best practices and requirements for human subject matter research.

We ask that you respond to our concerns explaining your relationship to the Heartland Study and agree to disclose all funding your institution and employees have received from this group – including any pass-through donors working as Heartland “fiscal sponsors” such as the Franciscan Health Foundation.

Notes:

[1] Not to be confused with the Heartland Institute – a completely separate, unrelated entity.

Read the original post here

Viewpoint: Exploiting chemophobia—Environmental Working Groups’s manufactured study claiming oat cereal contains dangerous pesticides designed to manipulate the media

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The Environmental Working Group (EWG) and media outlets are trying to scare people away from demonstrably safe and nutritious conventional food products.

Headlines about harmful pesticides in conventional foods are lying to you to create fear.

It is wildly irresponsible of supposed “journalists” to continue to platform this long-standing coordinated campaign by the EWG to erode science literacy and harm public health.

Some background: The Environmental Working Group (EWG) is a pro-organic activist organization funded by large organic farms like Earthbound, Organic Valley, Stony Field Farms, and Applegate Farms to demonize conventional products and encourage consumers to buy their products instead. EWG brings in $13 million dollars a year that funds their disinformation campaigns. This is the same group that creates the falsified “Dirty Dozen” list of conventional produce supposedly ‘contaminated’ (they’re not).

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EWG routinely exaggerates risks to consumers, promotes products backed by their donors, and uses flawed methodology to make claims not backed by legitimate data. EWG issues product safety warnings that have no evidence to support them. They are in opposition to modern agriculture, biotechnology, and have even spread unfounded claims about vaccine safety.

EWG is notorious for spreading fear about chemicals and exploiting chemophobia, the appeal to nature fallacy, and low chemistry literacy. The problem is, through their lobbyist arm, their disinformation impacts health policy and our laws.

The accuracy of EWG reports and statements has been criticized by scientific experts. Its warnings have been labeled “alarmist,” “scaremongering,” and “misleading”. Even though their claims are misleading, millions of people, even those making policy are influenced by disinformation they distribute.

While the EWG claims to help human health through research and by advocating for industry changes, in reality, they do the opposite.

EWG should never be utilized as an ‘expert source’ of information, even though they are routinely quoted by media outlets on topics related to chemicals and food.

Toxicologists and other scientific experts have detailed their flawed science and faulty research methodologies which they base their claims on.

  • They routinely make claims that are in direct opposition to credible scientific and medical agencies, their methods are not supported by any legitimate scientific organization, and frequently cite studies that are not peer-reviewed.
  • They exaggerate toxicological risks of chemicals, overstate potential impacts to human health, and take findings wildly out of context.
  • Their methods routinely implement chemophobic messaging and appeal to nature fallacies and utilizes fear-based marketing to scare consumers away from products that are demonstrably safe.
  • They frequently cherry-pick data that are favorable to their donor corporations, particularly claims related to unsubstantiated benefits of organic products and harms of gene technology, while simultaneously omitting more robust and relevant data.

The “science” EWG uses lacks credibility, but preys on emotions of consumers, leverages fear-based marketing, and coerces people into buying specific products.

Their newest fearmongering campaign? Oat-based cereals, supposedly because of harmful levels of chlormequat.

What’s worse? Media outlets are echoing this nonsense. Headlines like:

“Pesticide linked to reproductive issues found in Cheerios, Quaker Oats and other oat-based foods”

“Chemical That May Cause Infertility Found in Cheerios, Quaker Oats”

“80% of Americans test positive for infertility-linked chemical: Study”

To be clear: these claims are not truthful. Media outlets are sharing clickbait that demonstrates they didn’t even look at the study or the data.

Their website (linking for visibility, but don’t give them any more traffic), shows their history of demonizing chlormequat. Loaded and false phrases like “highly toxic”, “highly problematic”, “disrupts fetal growth”, “damages the reproductive system”, are everywhere, paired with a photo of a baby. ALL of this is designed to target your emotions, and NONE of this is supported by data.

Chlormequat has been around since the 1950s and is approved for use globallyIn the US, it is approved for ornamental plants as a plant growth retardant. It is primarily used in greenhouses and nurseries for geranium, poinsettia, begonia, African daisies, and hibiscus. Contrary to EWG claims, chlormequat is rapidly metabolized and degraded by plants, animals, bees, and soil microbes.

EWG wants everyone to believe that ANY chemical at ANY dose that isn’t ‘organically approved’ is TOXIC. They love using that word toxic, and they almost always use it without context.

With everything, the dose makes the poison.

Their war on chlormequat has continued with a recent self-funded ‘study’ from the EWG which they claim proves how widspread and harmful chlormequat is.

Their study “A pilot study of chlormequat in food and urine from adults in the United States from 2017 to 2023” is now being circulated by nearly every media outlet. Yes, it is highly irresponsible of media outlets to continually use EWG as a “credible” source – they couldn’t be further from it.

Main claims the EWG makes:

  • Detectable levels of chlormequat were in 92% of nonorganic oat-based foods purchased in May 2023.
  • Chlormequat was present in 77 of 96 (80%) of urine samples taken from 2017 and 2023, with levels increasing in the most recent years.

Detection does not equal clinical relevance.

This is a common strategy used by people who spread fear about certain chemicals (ironically, not other chemicals). Everything is chemicals. You’re a sack of chemicals. The dose makes the poison with everything. EWG employees seem to have forgotten all of this. The EWG’s foundation of fear-mongering is based on wild exaggeration of ‘detectable’ chemicals.

We have some of the most sensitive analytical chemistry tools on the planet. That means, we can “detect” levels of substances that are miniscule. Parts per billion. Parts per trillion. For context: a part per billion (ppb) is one part per 1,000,000,000 parts. A part per trillion (ppt) is one part per 1,000,000,000,000 parts.

A part per billion is equivalent to 50 drops of water in an Olympic-size swimming pool, or one second of time in approximately 31.7 years. A part per trillion is equivalent to 1 drop of water in 20 Olympic-size swimming pools, or one second of time in approximately 31,700 years.

Think about how small those values are for a minute. This is the range we are talking about when we talk about ‘detectable levels’ or ‘residues’ of pesticides. These are TRACE levels. TRACE levels do not equal clinically-relevant levels. Detectable does not equal meaningful.

Ok, let’s look at the data now. They claim 92% of non-organic oat-based products contained chlormequat. How many samples did they look at? How many different products did they test?

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Media outlets like CBS are using these data to say things like chlormquat is “showing up in the overwhelming majority of oat-based foods sold in the United States, including popular cereal brands Quaker Oats and Cheerios.” WRONG.

The overwhelming majority?! They looked at 25 samples in TOTAL. Twenty-five. Most of them from 3 name brands.

25 conventional oat-based products, 8 organic oat-based products, and 9 conventional wheat-based products, most from 3 major name brands were used. This is egregious cherry-picking. Do you realize how many different products exist containing oat and wheat?

As a good scientist, I looked at supplemental data to see what was actually tested.

Two Boxes each of:

  • General Mills Cheerios (one in May 2023 and one in June 2022).
  • General Mills Honey Nut Cheerios (one in May 2023 and one in June 2022).
  • Kellogg’s Special K Fruit & Yogurt one in May 2023 and one in June 2022).
  • Quaker Oatmeal Squares Honey Nut (one tone in May 2023 and one in June 2022).
  • Quaker Old Fashioned Oats (one in May 2023 and one in June 2022).
  • Quaker Instant Oatmeal Maple & Brown Sugar (one in May 2023 and one in August 2022).
  • Quaker Oatmeal Squares Brown Sugar (one in May 2023 and one in August 2022).
  • General Mills Cheerios Oat Crunch Oats n’ Honey (one in May 2023 and one in August 2022).
  • General Mills Frosted Cheerios (one in May 2023 and one in August 2022).
  • Quaker Simply Granola Oats Honey & Almonds (one in May 2023 and one in August 2022).
  • Quaker Chewy Dark Chocolate Chunk (one in May 2023 and one in August 2022).

One box each of:

  • Walmart Great Value Oats & Honey Granola
  • 365 Whole Foods Market Fruit & Nut Muesli
  • Good & Gather French Vanilla Almond Granola
  • 365 Whole Foods Market Organic Raisin Granola
  • Quaker Instant Oatmeal Organic Maple & Brown Sugar
  • Simple Truth Organic Instant Oatmeal Maple & Brown Sugar
  • Simple Truth Organic Oats & Honey Granola Clusters
  • 365 Whole Foods Market Organic Chocolate Chip Chewy Granola
  • 365 Whole Foods Market Organic French Vanilla Granola
  • 365 Whole Foods Market Organic Old Fashioned Rolled Oats
  • Simple Truth Organic Toasted Oats Cereal
  • Arnold Whole Grains Healthy Multi-Grain Bread
  • Band of Bakers Harvest Loaf
  • General Mills Cinnamon Toast Crunch
  • Gold Medal Premium Quality All Natural Whole Wheat Flour for Baking, 5 lb.
  • Great Value Half-Length Spaghetti
  • Kellogg’s Frosted Mini Wheats
  • King Arthur Flour All-Purpose Unbleached Flour
  • Nabisco Ritz Crackers
  • Nature’s Own 100% Whole Grain Bread

I need to emphasize that buying a single box of one specific product at one grocery store in Washington, DC during one specific date does not constitute the OVERWHELMING majority of oat-based foods.

They tested singular boxes of a selected array of various brands of food products for chlormequat. Already sounds like a fishing expedition. Let’s go back to that data table.

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Detected levels range from from ND, which means NOT detectable, to, at the very high end, 291 parts per billion. 291 parts per billion. Let’s visualize that.

291 parts per billion is 3 cups of water in an Olympic swimming pool (660,000 gallons). 291 parts per billion is equal to 4 minutes 51 seconds in 31.7 years.

Do either of these seem like a lot?

In a box of cereal weighing 14 ounces:

We’ll use the highest detected level of chlormequat for argument sake: 291 parts per billion, found in one box of Quaker Old Fashioned Oats in June 2022.

291 parts per billion. 291 parts per 1,000,000,000 parts. 291 g per 1,000,000,000 grams.

14 ounces is 396.893 grams. That means there was 0.0001155 grams of chlormequat in a 14-ounce box. That’s 0.1155 milligrams of chlormequat in an entire box.

That’s separate from the fact was one sample (of only 25), and the values measured ranged from undetectable. This is not how robust studies are conducted.

Let’s assume we happened to get that one box of Old Fashioned Oats and we ate the entire thing because we love oatmeal. We ate 0.1155 milligrams of chlormequat. Do we need to be concerned like the EWG and clickbait media outlets would have us believe?

How much chlormequat poses a risk to us?

Remember, the dose makes the poison for all things.

There are 2 levels set for regulated chemicals like conventional pesticides: acute exposure level and chronic (daily) exposure level. Acute exposure refers to what one can be exposed to in a single setting and not experience adverse effects (since our excretory system can only do so much work at once), whereas chronic exposure limit assumes daily exposure over one’s life.

Based on the body of scientific data (epidemiological, animal, in vitro, and in silico data) and likelihood of exposure, a no-observed-adverse-effect-level (NOAEL) is set. This is the value at which point no effect has been measured in ANY of the data related to that substance. Regulatory agencies set an even more conservative level to account for population-level variability in sensitivity to chemicals (e.g. young children, those with kidney issues whose excretory systems may be impaired). This is the population adjusted dose (PAD).

The NOAEL level for acute exposure is 100 milligram per kilogram body weight per day (mg/kg/day), and chronic exposure is 5 mg/kg/day.

The acute population adjusted dose (aPAD) for chlormequat is 1 mg/kg/day.

The chronic population adjusted dose (cPAD) for chlormequat is 0.05 mg/kg/day.

Both PAD values are 100 times lower than their respective NOAEL levels, meaning they are extremely conservative. But using the PAD levels:

An average adult weighing 70 kg (154 lbs) would need to consume 70 milligrams of chlormequat to reach the aPAD, equal to 606 boxes of cereal containing 291 ppb chlormequat in a single sitting.

An averge adult would have to consume 3.5 milligrams every single day for the rest of their life to reach the cPAD, equal to 30 boxes of cereal containing 291 ppb chlormequat.

So, do we really need to be concerned?

No. Trace levels of chlormequat in these products are not a concern to human health.

The EWG is doing what it always does: exploiting the fact that most people, even news outlets, won’t bother looking at the data, how weak the study was, and put those numbers into real-world context.

What about chlormequat accumulation in our bodies?

A common argument is, “we don’t know about the accumulation of these chemicals”. Chlormequat is rapidly excreted in our urine, meaning, it doesn’t accumulate, and our urine is doing what it should: removing things we don’t need. Over 60% of any ingested chlormequat is excreted in urine within hours (4-6 hours), and over 95% of it will be excreted within 46 hours. The EWG uses urine levels to insinuate that people are ingesting concerning levels of chlormequat, but in reality, anything detected in urine is waste.

Finding micro-trace levels of any chemical in urine is meaningless in and of itself. More than 3,000 chemicals can be detected in human urine; almost none poses any harm. Trace chemicals in urine are the residue of the kidneys doing its filtering job. EWG routinely assesses ‘urine levels’ of chemicals, either because they do not understand basic chemistry, or they are deliberately exploiting the widespread misunderstanding people have about how chemicals are processed by our bodies in order to spread fear.

But either way, let’s look at the data. They CLAIM that chlormequat was detected in 77 of 96 urine samples taken from 2017 and 2023, with levels increasing in recent years.

The data do not say that, at all.

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So, first off, they aren’t sampling from the same areas of the country over time. They look at 50 samples in Florida in 2023, then 23 samples in Missouri between 2018 and 2022, then 23 samples in South Carolina and Missouri in 2017. How do they know chlormequat use is simply higher in Florida where they sampled because there is a higher prevalence of ornamental plant nurseries? You cannot take completely different data sets from different parts of the world and say ‘oh levels are increasing’, because they aren’t matched data! And I feel like it needs to be repeated, but 50 samples here, 23 samples there; that does not make a robust data set to begin with.

Then they include data they didn’t even collect in a primary data table. From previously published studies, from Sweden? The major flaws in these data really underscore how if you suggest a peer-reviewer, you can get your paper approved for publishing (more on that in the future).

Let’s look at their data, figure 1B (1A is just linear representation of the same). These data are presented incorrectly to be misleading. It is presented as though these are longitudinal data, collecting from the same group over time. That’s wrong. These are entirely different collection sites and populations, and as such, there is zero normalization or standardization of these numbers.

Next, they compare chlormequat levels to excreted creatinine, a method which has inherent flaws as excreted creatinine is variable person-to-person. In addition, their units are manipulated to make this look meaningful. If they were actually normalizing to creatinine, units need to match. Instead, they’re using micrograms for chlormequat (1000-fold smaller than a milligram), and grams for creatinine (1000-fold BIGGER than a milligram) to make the data appear inflated. The data need to be divided by 1,000,000 in order to present as mg/mg.

It gets better. When you look at the data in the supplemental table, there are several data points where chlormequat was below the level of detection, yet somehow, they are reporting a value when they ‘normalize’ to creatinine? That sounds like data fabrication to me. If you don’t detect a value, you can’t just say the value is your level of detection. That’s called lying.

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Anyway, I went back to the supplemental data to correct for unit consistency. See below for the correctly represented data.

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Recreated data figure from S1 Data. Andrea Love, ImmunoLogic.

Looks different now. The data overlap, with no real changes in trace levels detected over the last 6 years, even if you ignored the fact that these data were not collected from the same locations. The mean value is 0.000002178 milligrams of chlormequat per milligram creatinine in urine.

Average creatinine in urine ranges from 20–275 mg/dL in women and 20–320 mg/dL in men (1 dL = 100 mL). AAverage urine output is 800-2,000 mL per day. Some more quick math: assuming an average of 100 mg/dL creatinine for the ‘subjects’ and 1000 mL of urine per day – both of these values are squarely mid-range:

0.000217 mg of chlormequat/dL of urine x 10 dL (for a liter) = 0.00217 mg chlormequat on average these people are peeing out.

1 ppb = 1 microgram/L, so this level is equivalent to 2.17 parts per billion. 10-fold lower than the completely benign levels in cereals.

The cPAD level is 0.05 mg/kg/day (that’s the most conservative exposure limit), 3.5 mg for a 154 lb person. Chlormequat is rapidly excreted in urine and residual levels aren’t hanging out in the body.

These values of what someone in this study might be peeing out in a day are 1,613 TIMES LOWER than the most conservative level set by regulatory agencies for chlormequat exposure.

These trace levels “detected in urine” are not remotely physiologically relevant.

They also claim that chlormequat is linked to infertility and birth defects in animals, and therefore, we should also be concerned about fertility and birth defects in humans.

How much chlormequat impacts fertility in animals?

Based on the body of evidence, a lot. Not remotely anywhere near levels humans would ever encounter.

Long-term studies among rats who were given 1,000 parts per million (that’s 1,000,000 parts per billion, so 3,448 times higher levels than what was ‘detected’ in that one box of oatmeal by the EWG) found no impact on fertility, fetal development (teratogenicity), or development of young rats. Recent studies have found similar, including in larger mammals like boar.

The EWG, and every major news outlet that has picked up this flawed study and reported on it without even looking at the methods or the data are contributing to spreading disinformation and exacerbating health anxiety.

The EWG is lying to you about what are real concerns and what aren’t when it comes to our food. This study doesn’t demonstrate any of the claims they are making, but their PR team and their figureheads have lines of contact to media outlets who foment fear with clickbait headlines and misrepresentation of reality.

If you see someone citing the Environmental Working Group as a source, do not trust what they say. EWG has a long and documented history of falsifying claims.

Disinformation like this (yes, these are intentional false claims) is the cornerstone of EWG’s business model. They are eroding trust in science and literacy, and are a danger to public health.

If you found this useful, please share with friends and family, especially though who fall prey to fear-based headlines. If you know a reporter who has written on this or other EWG claims, please send it to them as well. I’ve seen headlines from nearly every news outlet, including CBS, Fox, NewsNation, Forbes, MarketWatch, and others.

Anti-science rejection and science misinformation is a global public health threat. This is no time to be complacent about this. This discussion is not about “industry” or “government” – it is about activist organizations and the media outlets they have relationships with spreading lies about scientific data. All of us can help combat the spread of these falsehoods.

Dr. Andrea Love, a microbiologist and immunologist, provides the facts (and the data!) on science and health topics. Find Andrea on X @dr_andrealove

A version of this article was originally posted at Andrea Love’s blog ImmunoLogic and is reposted here with permission. Any reposting should credit both the GLP and original article. 

Viewpoint: UK’s organic farming lobby needs to drop its ideological rejection of gene editing if it hopes to remain viable

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In July [2023], the European Commission published its proposals for regulating plants developed using new genomic techniques (NGTs) such as CRISPR gene editing.

This followed a report published by the Commission in April 2021, reviewing the impacts of a July 2018 ruling by the European Court of Justice that all NGT plants should be regulated in the EU as genetically modified organisms (GMOs).

The Commission’s review determined that the EU’s 20-year-old regulatory framework for GMOs was not fit-for-purpose to deal with more recent breeding technologies such as gene editing. It also advised that regulatory reform for NGTs was needed to support EU agriculture’s response to urgent climate, food security and environmental challenges.         

Central to the EU’s deregulatory plan is the re-classification of NGTs into two distinct product groups. Category 1 products, which could have occurred in nature or through conventional breeding, will be exempt from GMO regulations, with no separate requirements for risk assessment, traceability, labelling or co-existence. Category 2 products, incorporating changes which could not have occurred naturally, will continue to be subject to GMO-style risk assessment.   

The EU definition of Category 1 products is very similar to the Precision Bred Organisms (PBOs) established by the Genetic Technology (Precision Breeding) Act in England, and also mirrors the regulatory classification adopted in other countries, such as Canada, Japan, Argentina and Brazil.

But while the planned regulatory changes may be aligned on both sides of the Channel, the response from the organic lobby could hardly be more at odds.  

Here in the UK, a more streamlined and evidence-based approach to regulating these new genetic technologies has met with outcry and outrage from organic bodies such as the Soil Association and Organic Farmers & Growers, whose leaders claim the interests of organic producers will be put at risk without strict labelling and traceability requirements to support zero tolerance of gene editing.     

On the Continent, the reaction is much more mixed.

So, for example, Danish organic body Økologisk Landsforening (Organic Denmark), has publicly questioned the proposed ban on NGTs in organic farming, suggesting that this position should be reviewed with gene editing techniques expected to become widespread in conventional plant breeding.

This is a view shared by organic dairy farmer Lone Andersen, Vice President of the Danish Agriculture and Food Council, who believes organic farmers need access to innovation, including new genomic techniques, to be sustainable.

Meanwhile Thor Gunnar Kofoed, another leading organic farmer who chairs the seed working group of the European farmers association COPA-COGECA, recently suggested that, as an organic farmer himself, and in conversation with other organic producers, “they all want to use NGTs”, because they know that being excluded from new varieties used by conventional farmers will make them increasingly uncompetitive.  

In Brussels, progress towards the adoption of the Commission’s plans has moved surprisingly quickly.

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Following publication of the Commission’s draft regulations in July, many Brussels commentators confidently predicted that the proposals would become delayed and bogged down by political opposition in the European Parliament and Council of Ministers, and that more red tape and restrictions would be added.

In fact, last month’s draft report from the European Parliament’s Environment Committee, which has lead responsibility for scrutinising the Commission’s plans, has proposed an accelerated timeline for MEPs to deal with the file, with the aim of finalising the Parliament’s position during the January 2024 plenary session.

Significantly, the Environment Committee report includes proposed amendments which would permit the use of Category 1 NGT plants in organic production, and which would remove the Commission’s plans for mandatory labelling of Category 1 NGT seeds, instead focusing on publicly available information, such as variety registers, to support transparency and traceability objectives.

Interestingly, the Estonian government recently announced that it not only backed the Commission’s NGT proposals, but would also support moves to allow gene editing in organic agriculture, noting that in its consultations on the plans: “Estonian organic producers were not opposed to the draft regulation.”  

These developments in recent months suggest a major split in the EU organic lobby, based on a recognition that gene editing is set to become commonplace in conventional plant breeding, and that it could deliver major benefits to organic producers.  

As East Yorks mixed farmer Paul Temple recently pointed out, if the organic lobby maintains its dogmatic opposition to gene editing, “organic growers may be left with older genetics gradually becoming more and more outclassed, more prone to disease and pest infestation, further widening the productivity gap between organic and non-organic.”

Here in Britain, I am equally concerned that a growing rift is emerging between the views expressed by those in charge of the organic sector bodies, and the grassroots opinions of many organic producers, for whom gene editing is seen as ‘manna from heaven’ as a means of closing the yield gap between conventional and organic production. 

As a registered organic processor, I do not recall being asked for a view on whether UK organic standards should prohibit the use of these faster, more precise breeding techniques.

How can organic standards seriously endorse the random mutagenesis of entire genomes using chemicals and nuclear radiation, while prohibiting the use of these more targeted approaches?  

As pressure builds to permit gene edited crops in EU organic agriculture, Britain’s organic farmers risk being left behind if the campaigning stance of UK organic sector bodies does not reflect the views of members on the ground.        

Surely it is time for Britain’s organic industry to have an open-minded discussion, focused on the potential use of these techniques to align with the objectives of a more productive, resilient and competitive organic sector? 

David Hill farms in central Norfolk growing early generation cereal seed, grass seed, oilseed rape, sugar beet and spelt wheat. The farm also operates three processing plants, adding value to its own and other farmers’ crops. David is a Nuffield Scholar and a member of the Global Farmers Network. A keen advocate of new technology in agriculture, he was one of the first farmers to host UK trials of GM sugar beet as part of the Government’s GM crop Field Scale Evaluation trials in the late 1990s.    

A version of this article was originally posted at Science for Sustainable Agriculture and is reposted here with permission. Any reposting should credit both the GLP and original article. Find them on X @SciSustAg

Russia’s shadowy disinformation war against the United States and its allies — Here are some of its key targets  

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Russia’s decades-old propaganda machine seeks to damage the health and prosperity of the country’s adversaries. Ukraine and the United States are tops on their list of targets.  

Russian President Vladimir Putin ordered his administration’s political strategists to use social media and fake news articles to try to create divisions within Ukrainian society, according to a trove of Kremlin documents obtained by a European intelligence service and reviewed and reported on by the Washington Post. The Russian propagandists focused on messages that would destabilize Ukraine by fomenting or exaggerating divisions within the country’s leadership, efforts that Moscow calls “information psychological operations.”

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This is nothing new for Russia, which maintains a massive propaganda apparatus, manned by bots, trolls, and (pseudo-) journalists. For decades, the U.S. and other Western countries have been the target of such operations, which mushroomed during the COVID-19 pandemic.

Anyone active on social media is aware that there is a great deal of passionate but ill-founded opposition to vaccination, especially the COVID-19 vaccines. Some of it was grassroots, but a lot was driven by organized rejectionists, with Russia at its core. As reported in the science journal Nature, they were people “running multi-million-dollar organizations, incorporated mainly in the USA, with as many as 60 staff each.”

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How Russia conducts its campaigns

One example: Russia’s fingerprints were all over a cartoon posted on a far-right discussion forum that suggested the Biden Administration was about to order mandatory vaccinations. It showed police officers wearing bulletproof vests with Biden-Harris campaign logos and battering down a door with a large syringe. A caption read in part, “In Biden’s America.”

The inflammatory cartoon and similar campaigns were traced to a Russian troll farm whose mission was to stir political trouble in the U.S. It cultivates and exploits foreign anti-vaccine “useful idiots,” causing palpable harm to Americans and citizens of other Western countries.

This is part of a much broader and long-standing pattern of attacks by Russia, which are often spread by politicians the Kremlin views as easy dupes. As journalist and historian Anne Applebaum wrote in 2021 in The Atlantic:

For decades now, Russian security services have studied a concept called ‘reflexive control‘—the science of how to get your enemies to make mistakes. To be successful, practitioners must first analyze their opponents deeply, to understand where they get their information and why they trust it; then they need to find ways of influencing with those trusted sources, in order to insert errors and mistakes. 

This sort of manipulation has huge implications for public health; consider how incorrect information might be picked up by crazies — aka “useful idiots,” a term popularized by Vladimir Lenin — in high-level political positions and find its way into policy discussions. Examples include useful idiots extraordinaire Rep. Majorie Taylor Greene (R-Ga), presidential candidate Robert F. Kennedy, Jr., and Florida Surgeon General Joseph Ladapo.  

Health propaganda

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An anonymous letter in Patriot, a small newspaper published in New Delhi that was later revealed to have received Soviet funding. Credit: History, Philosophy, and Newspaper Library at the University of Illinois at Urbana Champaign

I have previously described how Russia has long conducted health-related disinformation and propaganda campaigns intended to humiliate or disparage the country’s foreign enemies. 

In the 1980s, the Soviet Union concocted an elaborate disinformation scheme to blame the appearance of HIV and AIDS on U.S. military research. They first planted the story in a sympathetic Indian newspaper, then followed it up with other fake stories that cited the initial report.

A 2018 U.S. Senate-commissioned analysis by New Knowledge, a cybersecurity firm, confirmed that Russia’s infamous troll factory, the Internet Research Agency, conducts “modern information warfare” against its adversaries. Renee DiResta, New Knowledge’s research director, described the IRA’s battle plan as a “cross-platform attack that made use of numerous features on each social network and that spanned the entire social ecosystem.”

study published by academics in 2018, “Weaponized Health Communication: Twitter Bots and Russian Trolls Amplify the Vaccine Debate,” found that thousands of Russian social media accounts were spreading anti-vaccine messaging, even well before COVID.  

From an examination of almost two million tweets posted between 2014 and 2017, the researchers found that Russian troll accounts were significantly more likely to tweet about vaccination than were Twitter users generally. 

They noted that Russian tweets like, “Apparently only the elite get ‘clean’ #vaccines. And what do we, normal ppl, get?!” seemed intended to exacerbate socioeconomic tensions in the United States.

Russia’s anti-vaccine mischief accelerated during the pandemic. Using online publications to raise concerns about the rapidity of the coronavirus vaccines’ development and their safety, they conducted an aggressive campaign to undermine confidence in the Pfizer-BioNTech and other Western COVID vaccines.

As reported in the Wall Street Journal in 2021:

Russian state media and Russian government Twitter accounts have made overt efforts to raise concerns about the cost and safety of the Pfizer vaccine in what experts outside the U.S. government say is an effort to promote the sale of Russia’s rival Sputnik V vaccine.

Disinformation tactics

In the past, the Russian disinformation accounts also posted pro-vaccine messages, to give the illusion of genuine controversy while attempting to exploit a wedge issue and foment social discord, erode trust in public health institutions, and elicit mistrust of pharmaceutical companies.

Russia has become an expert at leveraging divisive issues to further its trouble-making efforts. In 2017, tweets from Russian troll accounts created a synergistic link between vaccine denial and U.S. racial divides. For example, “Diseases Expert Calls for White Genocide Since Most Vaccine Deniers are White” was tweeted by several Russian trolls. DiResta believes the Russians’ motive is “opportunism—opportunistically amplifying controversial topics,” but the bottom line is that Russian agitprop campaigns stoke controversy over vaccination to both divide and injure Americans.

There is also evidence that for decades Russia has attempted to sow distrust and skepticism to undermine key U.S.-dominant industries. Russia’s, propaganda machine feeds disinformation to the well-financed, U.S.-based anti-genetic engineering movement  (here and here). U.S. Right to Know (USRTK), the most aggressive of the anti-science environmental groups in the United States, and the outlet RT (formerly “Russia Today”) have the same objective: to undermine support for genetic engineering in agriculture.

The ideological far left has often been dupes. Consider the bizarre 2017 story claiming that First Lady Melania Trump banned genetically engineered foods from the White House and favored organic products. Much of the article, including some of the quotes attributed to the first lady, was cribbed verbatim from a 2010 Yes! magazine article that had nothing whatever to do with her. Yes! is a radical left-wing publication devoted to “social justice, environment, and health and happiness.”screenshot at  pm

The Melania article originally ran on Your News Wire, another fake news source linked to Russia. The author, “Baxter Dmitry,” has penned pieces for that outlet which allege, among other things, that “Sweden Bans Mandatory Vaccinations Over ‘Serious Health Concerns‘” (untrue, but there’s the vaccine connection again) and that a “former Hillary Clinton employee” was “arrested for treason”  (untrue). He also wrote in 2017 that Melania Trump “has credited the healing and nurturing properties of nature for her good health, and urged Americans to stop leaning so heavily on Big Pharma to provide ‘magic potions’ to cure their ills” (untrue).

In 2018, two Iowa State University researchers, Shawn Dorius and Carolyn Lawrence-Dill, looked at the source of articles containing the word “GMO” (genetically modified organism) and how genetic engineering was portrayed. They found that Russia’s English-language propaganda outlets RT and Sputnik produced more “GMO” articles than five other major news organizations — Huffington Post, Fox News, CNN, Breitbart News, and MSNBC — combined.

The two Russian outlets together accounted for more than half of all the GMO-related articles among the seven sites (RT, 34%; Sputnik, 19%), and “RT and Sputnik overwhelmingly portrayed genetic modification in a negative light,” the researchers wrote. The researchers also found that RT published “nearly all articles in which the term GMO appeared as ‘clickbait.'”

Their efforts to undermine biotechnology innovation have escalated in recent years, taking on a political bent. In 2022, RT favorably mentioned Trump-backed Pennsylvania Senate candidate (and notorious TV quack) Mehmet Oz for “butting heads with Big Pharma and the GMO food lobby.” The site also promotes conspiracy theorist and genetic engineering antagonist Vandana Shiva and claims, without evidence, that Bill Gates exploits the war in Ukraine to advance genetically modified crops.screenshot at  pm

According to Dorius and Lawrence-Dill,

Russian misinformation attacks reflected the full spectrum of anti-GMO attitudes, covering, for example, environmental concerns (cross-pollination, species loss, chemical pollution), health risks (a cause of cancer, Zika), nutritional deficiencies, political corruption, negative social and economic consequences for developing countries (suicide of Indian farmers), corporate malfeasance (manipulation of facts by Monsanto), and corruption of federal regulatory agencies. The extensive nature of Russian News portrayal of GMOs reflects a deep understanding of the psychological antecedents of public distrust in bioengineering and an intent to more firmly link these antecedents in the public consciousness.

Why is crop biotechnology such a frequent target? Dorius explains

GMOs are deeply connected with international trade, environmental and food policy, and the strategically important issue of food security… That we are seeing a pattern of contrast between the U.S. model of agriculture, and what Russian news frames as a cleaner, alternative agriculture system, suggests that there may be different, or additional motivations.

In 2016, Russia placed a ban on commercial GMOs, making goods produced in Russia more favorable to Yes! magazine-type consumers. But Russia’s rejection of genetic engineering and its embrace of “agroecology,” a vaguely defined concept that embraces allegedly more natural but lower-yielding agricultural techniques, ultimately dooms it to fall ever-farther behind the modern agriculture of the West. Because Russia lags so far behind, both in sophistication and the amount of genetic engineering research and development it conducts, its government has adopted a strategy of aggressively trying to demean and discredit other countries’ higher-tech efforts. By discouraging the acceptance of modern genetic engineering techniques abroad, Russia hopes to prevent the gap between their and others’ agriculture from becoming a chasm.

The actions of the Russians and their U.S.-based useful idiots are a throwback to the malevolence of the Stalin era: promote discord, create mistrust of U.S.-dominant industries, and damage America’s health, ability to innovate, and productivity. These attacks are growing in scale, sophistication, and effectiveness. Isn’t it time we did something about it?

Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. He was the founding director of the FDA’s Office of Biotechnology. Find him on Twitter @HenryIMiller

What’s driving the ‘multi-billion dollar fear-and-smear campaign against genetically-engineered crops’ — and the link between activists and Russia?

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Because most of society is between two and six generations removed from farming, to many people that subject is largely terra incognita, literally and figuratively. This lack of knowledge makes the public very susceptible to disinformation and the fear-based marketing of food. 

It’s been said before but is worth repeating: Humans have been modifying the DNA of our food for thousands of years. It’s called … agriculture. Early farmers, >10,000 years ago), used selective breeding to guide DNA changes in crops to better suit their needs. Approximately a hundred years ago plant breeders began using harsh chemicals and/or radiation to create random mutations in the DNA of crop plants to, for example, turn bitter grapefruits into a sweet varietal. These mutagens caused innumerable changes to the DNA, none of which was characterized or examined for safety. Problems were rare, similar to what we see in conventional, pre-mutagenesis breeding. Today more than half of all food crops have mutagenesis breeding as part of their pedigree. 

As a result of the use of a variety of techniques for genetic modification, including selective breeding, mutagenesis, somaclonal variation, and wide crosses, ancestral varieties bear little resemblance to the domesticated crops we eat today.  There are many striking pictorial examples here.

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Credit: James Kennedy

Several decades ago, agricultural scientists and plant breeders began to use recombinant DNA technology (“gene splicing”) to make far more precise and predictable changes in the DNA in our crops. This molecular genetic engineering (GE) enables plant breeders to take, for example, a bacterial gene with a known function (e.g., toxicity to certain insect predators) and transfer that trait into a crop.  In that instance, it enables the GE crop to naturally protect itself from insect pests. This one trait has allowed farmers around the world to reduce broad-spectrum insecticide spraying by billions of pounds while raising yields. 

More recently, new techniques to perform genome-editing, or gene-editing, have emerged, making genetic modification even more precise, predictable, and versatile. CRISPR-Cas9 is the prototype.

One would think that environmental non-governmental organizations (eNGOs) would cheer such innovation. Sadly, this is not the case; no good deed goes unpunished. Activists (many of whom benefit financially from their advocacy) have teamed up with companies that sell organic and “natural” food products to vilify “GMOs” (genetically modified organisms), crops crafted with molecular techniques. 

This anti-genetic engineering industry and its lobbyists are primarily responsible for the public apprehension towards this technology. They have been very successful at generating fear about “GMOs” in the public. They then use that fear to sell dubious, overpriced organic or “non-GMO” food products and supplements to an unsuspecting public. 

Even worse are the environmental NGOs’ attempts to prevent the creation and distribution of new, life-saving crops. “Deficiency of vitamin A is associated with significant morbidity and mortality from common childhood infections, and is the world’s leading preventable cause of childhood blindness,” according to the World Health Organization. There is a genetically engineered solution to it, but Greenpeace, one of the world’s most notorious environmental NGOs, has convinced a Philippines court to block the distribution to the poor of Golden Rice, which contains the precursor of vitamin A. The result will be more malnutrition, blindness, and deaths of children. Greenpeace’s actions should be the target of global outrage.

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Golden Rice. Credit: IRRI/Flickr (CC BY-NC-SA 2.0)

This same global anti-technology industry lobbies for unnecessary and expensive regulatory barriers for gene-edited crops and animals. They have had success in Europe and Africa and, most recently, in Mexico. One of their specious claims is that high, albeit unnecessary, regulatory barriers promote consumer confidence. That’s cynical, and untrue.

Thirty-plus years of excessive regulation of genetic engineering has neither reduced public anxiety nor quieted the critics. If anything, these regulations have fanned public concerns about these safe, superior technologies. As Barbara Keating-Edh, representing the consumer group Consumer Alert, testified to the U.S. National Biotechnology Policy Board way back in 1991:

For obvious reasons, the consumer views the technologies that are most regulated to be the least safe ones. Heavy involvement by the government, no matter how well intended, inevitably sends the wrong signals. Rather than ensuring confidence, it raises suspicion and doubt” [emphasis in original]. (Keating-Edh, B. Statement before the National Biotechnology Policy Board (20 September 1991), cited in Biotechnology Law Report, March-April 1993, 12 (2); 127-182.)

 We have more than a quarter century of experience with commercialized GE crops; literally thousands of assessments by governments and scientific organizations have found that GE crops are as safe, or even safer, than crops made using conventional breeding methods. Putting it another way, there is no evidence that the use of molecular genetic engineering techniques confers unique or incremental risks.

It seems that consumers crave technology and technological advances in every aspect of their lives—except in food production. They have welcomed the advent of hybrid engines and shoulder belts in cars and enthusiastically embraced smarter and more versatile phones, they love their seedless watermelons and almost endless apple varieties, but many are suspicious of genetic modification with the newest, best techniques. 

Why is that? It is largely because of a decades-long, multi-national, multi-billion-dollar fear-and-smear campaign against genetically engineered crops and foods by the anti-genetic engineering machine. Largely funded by the organic and natural products industries and tort lawyers who cash in on class action suits settled by companies just to get them off the court docket, it attacks not only companies capable of producing breakthroughs but also individual academics and ordinary citizens who endorse the kind of science-driven public policy that will promote future advances. To increase its clout, rejectionist organizations like Environmental Working Group and US Right to Know have made common cause with the anti-vaccine movement. 

The cabal is not just home-grown. Russia’s disinformation/propaganda apparatus has long been involved in disparaging genetic engineering, in part to foment trouble in Western countries. Who would be surprised if paid domestic internet “influencers” were also involved?  

Technology has helped to double food production in the last 50 years. We have the cheapest, safest, most abundant food supply in history, but the enemies of progress continue to attack the technologies that have made that possible.

Henry I. Miller, a physician and molecular biologist, was the founding director of the FDA’s Office of Biotechnology and now is Glenn Swogger Distinguished Fellow at the American Council on Science and Health. Find Henry on X @HenryIMiller

Rob Wager is a retired scientist from Vancouver Island University, but he continues his work as a researcher on genetically engineered crops.

This article previously appeared on the GLP June 21, 2023.

Probiotics are ‘enticing target’ for gene editing — but is CRISPR up for the challenge?

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Every morning I pop a Pearl probiotic. I try hard not to drop it, for the tiny, slippery yellow sphere bounces, is impossible to pick up, and cats love to bat them into unreachable domains.

A probiotic is, technically speaking, a population of live microorganisms that confers health benefits on the multicellular organism that they inhabit – such as a human. Probiotics alter the bacterial, viral, and fungal milieu within and on us – our microbiomes – in ways that ease digestion, counter inflammation, strengthen the gut lining, affect brain function, and even squelch tumors.

Each Pearl – or other variation on the probiotic theme – delivers billions of Lactobacilli to the twists and turns, nooks and crannies, of the human host’s intestines, maintaining the microbial community within and keeping digestion flowing along smoothly. Other commonly used probiotics are Bifidobacterium and the yeasts Saccharomyces cerevisiae and boulardii.

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Credit: Nature’s Way

Borrowed from bacteria

Researchers are using the gene editing tool CRISPR to improve upon naturally-evolved human microbiomes, to build a better probiotic. CRISPR technology can introduce quality control and perhaps also tailor microbial activities in a reproducible manner, aiming to improve upon and standardize the dynamics of how the helpful microbes inhabit our insides. But will it, can it, improve upon nature?

The molecular tools of CRISPR were borrowed and developed from the natural immune response of bacteria to viruses – bacteriophages – that infect them. CRISPR reinvented as a tool can enable the precise combining of and swapping of genetic instructions between and among microorganisms in ways that might not occur in nature. The technology can also endow specific species with novel characteristics that could benefit human hosts.

Probiotics are an enticing target. Already, engineered probiotics have been used to treat metabolic disorders like inflammatory bowel disease and obesity, single-gene conditions like PKU, and bacterial infections common in people who have cystic fibrosis. Probiotics can also be tweaked to minimize development of antibiotic resistance.

A recent paper in BioDesign ResearchCRISPR-Cas-Based Engineering of Probiotics, from investigators at several Chinese research institutions, contributed to the report.

They write:

Genome engineering of probiotics, including the editing of the genome to introduce, remove, or modify phenotypes, will improve their tolerance to stress during food production, promote their survival in the gastrointestinal tract, or enhance their probiotic function. The development of genome engineering and synthetic biology has greatly promoted the construction of novel probiotic strains with desired functions, which has facilitated the treatment of metabolic disorders, inflammation, pathogen infection, and even cancer.

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The role of evolution

Human microbiomes have evolved over many millennia, molded by and attuned to the viruses, bacteria and other single-celled microbes, and fungi that dwelled in the digestive tracts of our ancestors.

Several species of australopithecines, for example, lived in Africa 2 to 4 million years ago. They overlapped with the species of Homo that would persist and eventually give rise to the archaic humans (Neanderthals and Denisovans), more than 200,000 years ago.

These ancestors dwelled in geographically limited areas. Over deep time, their microbiomes came to reflect the diversity of species that lived on and in them. Such a natural microbiome is far different from those of people living today, able to eat diverse foods from many places.

That’s a lot of evolution, as well as symbiosis. The driving force of evolutionary change, natural selection, favors inherited traits that enable an organism to survive to reproduce, while eliminating traits that impair reproduction. Natural selection, then, would have sculpted microbiomes.

And so modern human microbiomes emerged over millennia in ways that enabled their hosts – our forebears – to have healthy, fertile offspring. Can a biotechnology, even one borrowed from bacteria to begin with, accomplish as complex an action as the natural evolution of microbiomes? I’m not so sure.

Stick to single-gene challenges?

CRISPR may make sense for replacing a single mutant gene, like the one behind sickle cell disease, for which a CRISPR-based gene therapy was recently approved. But emulating a microbiome, a complex assortment of cells and viruses, is, I think, a technically more challenging venture. Sometimes, nature may be better.

Meanwhile, though, researchers have come up with eclectic but more focused applications of CRISPR technology, which can add, remove, replace, or fix genes. The goals include:

Refining fish farming

CRISPR can remove genes that encode hormones that catfish require to reproduce. With additional genetic modifications, the fish  can be raised on farms where the hormones are added to the water. They cannot survive in the wild.

Bringing back extinct species

“De-extinction” replaces genes in modern organisms with counterparts from extinct relatives, such as an elephant with mammoth genes, or a heath hen with chicken genes. DNA Science recently covered perfumes resurrected from extinct plants, but using older and less precise recombinant DNA technology.

Limiting spread of infectious diseases

Harness CRISPR to introduce genes into disease vectors, such as mosquitoes and ticks, which render them infertile. Or, add genes to arm a host species to resist a specific infectious disease. CRISPR can perhaps even swap in a mutation (CCR5) to provide resistance to HIV.

Creating organ donors

Introduce human genes into the genomes of pig fertilized ova to create an animal whose cell surfaces the human immune response will not reject when pig organs are transplanted.

Adding traits to show animals

Introduce genes for valued traits (such as fur color, body size, and stamina) into pets or show animals in just one or two generations.

Beef production

Add a gene conferring a short, slick coat that enables cattle to tolerate heat. And at the same time, remove the distinctive sialic acid molecules that dot the surfaces of beef muscle cells, causing inflammation in human burger lovers.

With CRISPR, possibilities are limited only by our imaginations. But we perhaps shouldn’t bite off more than we can chew!

Ricki Lewis has a PhD in genetics and is the author of the textbook Human Genetics: Concepts and Applications, soon to be published in its fourteenth edition. Follow her at her website www.rickilewis.com or X @rickilewis

A version of this article was originally published at PLOS Blogs and has been republished here with permission. PLOS can be found on X @PLOS

GLP podcast: Neuralink chip in your brain? CNN’s bunk COVID booster headline; Obesity drugs—the long-term effects

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Neuralink has successfully implanted its “brain–computer interface” in a human patient. Elon Musk says the results so far are “promising.” What does that mean exactly? CNN recently exaggerated the risk of COVID boosters, undermining efforts to quell groundless fears about the shots. Weight-loss drugs Ozempic and Wegovy have proven to be both effective and popular, but critics say these pharmaceuticals raise serious ethical concerns that must be addressed.

Podcast:

Join hosts Dr. Liza Dunn and GLP contributor Cameron English on episode 253 of Science Facts and Fallacies as they break down these latest news stories:

Incendiary billionaire Elon Musk says his goal with Neuralink is to “achieve a symbiosis with artificial intelligence” using implantable brain–computer interfaces. In essence, the company aims to implant chips in people’s brains so they can operate computers with their thoughts. Widespread use of this technology is a long way off, but Neuralink’s coin-sized microchip, known as “Telepathy,” could sooner improve the lives of quadriplegics, patients who experience paralysis in all four limbs. One individual has already received the implant, and Musk says the next step is a six-year clinical trial to determine if the product is a viable long-term treatment. 

The media routinely misreport scientific facts to the public. But even when news stories are more or less correct, their headlines can still be misleading—a serious issue since so many people only read headlines. CNN published a case study late last year in a story reporting a rare risk associated with COVID and flu vaccines in the elderly. The article rightly reported that fewer than three people out of 100,000 experienced stroke after receiving both shots—an exceedingly low incidence rate. However, the story’s title implied that the COVID booster significantly increased the risk of stroke for older patients. Moral of the story? Headline writers should read the article before composing its title.

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Initially developed as treatments for type 2 diabetes, Ozempic and Wegovy are now widely used as effective interventions for obesity. The same active ingredient in both drugs regulates the effects of two hormones, insulin and glucagon, reducing appetite and slowing digestion. Patients feel “full” for longer and consume fewer calories as a result. But these blockbuster drugs have come under scrutiny from critics who say they’re too expensive, aggressively marketed and unable to treat the underlying causes of obesity. Just how worried should we be?

Dr. Liza Dunn is a medical toxicologist and the medical affairs lead at Bayer Crop Science. Follow her on X @DrLizaMD

Cameron J. English is the director of bio-sciences at the American Council on Science and Health. Visit his website and follow him on X @camjenglish

England’s gene-editing rules could be far more restrictive than scientists hope

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In proposals set out in a recent public consultation document, the Food Standards Agency has confirmed its plans for implementing the food and feed marketing aspects of the Genetic Technology (Precision Breeding) Act, which received Royal Assent in March [2023]. In summer 2024, the Government intends to bring forward secondary legislation to enact these arrangements, which if passed by Parliament would then come into force at the beginning of 2025.

The Food Standards Agency (FSA) has certainly come a long way in its thinking since [summer 2022], when FSA chief scientist Professor Robin May warned that speed of development was a major risk factor with precision breeding techniques, since it meant less time and opportunity for developers to check the safety of their products. Or when the former FSA vice-chair Ruth Hussey suggested that post-market surveillance would be needed to track precision bred (PB) products, like new medicines, for unexpected health effects.

Indeed, until relatively recently, it appeared that the Agency was planning to apply a full regulated product approval process to the authorisation of all PB food and feed products, including separate food safety risk assessment, expert committee scrutiny, public consultation, approval by both Houses of Parliament and Secretary of State sign off.

Such an approach would be entirely disproportionate to the scientific evidence of risk associated with precision breeding, totally at odds with the underpinning rationale of the Act that PB products are no different from conventional, and out of line with the prevailing regulatory position in other countries around the world, including the EU.

A lengthy regulated products process would also become unworkable within a relatively short period, since precision breeding techniques are expected to be in routine commercial use within the next 5-10 years, with hundreds of new crop varieties likely to be released each year both here and around the world.    

It would also be the ultimate irony if the European Union, from whose restrictive laws on GMOs and precision breeding we originally sought to diverge, ended up with more progressive and enabling arrangements than our own!   

Indeed, a major turning point in the FSA’s thinking appears to have been triggered by the publication in July of the European Commission’s plans for regulating plants produced using gene editing, or new genomic techniques (NGT), in the EU.    

The EU is proposing a simple notification process for Category 1 NGT plants (those which could also occur naturally or through conventional breeding), regulating them as conventionally bred, with no additional GMO-style requirements for risk assessment, traceability or labelling. 

This approach is mirrored in the FSA’s plans for a two-tier system, with developers required to self-determine tier status according to (yet to be published) technical guidance. Like the EU’s Category 1 NGT products, Tier 1 would be equivalent to well-characterised, conventionally bred products, and would require notification to FSA prior to marketing.

However, the information requirements set out in the FSA consultation document for Tier 1 products do give some cause for concern that the Agency has not entirely accepted the scientific advice that PB food and feed products introduce no new or additional food safety risks.     

For example, the basic (Model 1) information requirements range from factual details of the nature and purpose of the genetic change, as well as the intended uses and history of safe consumption of the species, to much broader questions, such as a description of the measures taken to minimise ‘off-target’ effects, or to check for antinutritional factors.   

Without clear technical guidance, these potentially ‘open-ended’ information requirements run the risk of mission creep towards a risk assessment-type approach. They could also attract widely differing responses from applicants in terms of the level of detail submitted, which in turn could set regulatory precedents or expectations which are disproportionate to any evidence of risk.    

To have the confidence to invest in research, innovation and product development, developers need regulations that provide clarity, predictability and certainty. They will also be keen to ensure that regulatory requirements are future-proofed against the possibility of a change of Government, and the pressure a prospective Labour administration might come under to block or delay these technologies.  

Given that Defra will have already assessed and confirmed these products as PBOs, and therefore equivalent to conventionally bred products, FSA must explain the value and purpose of this information, particularly in relation to so-called ‘off-target effects’: firstly because the primary objective of the breeding process is to remove unwanted characteristics, and existing statutory requirements check that new varieties are genetically uniform and stable; secondly because these are potentially open-ended questions (it is not possible to prove a negative); and thirdly because no off-target effects identified could possibly be attributed to the precision breeding process, since natural mutations are happening all the time.

Greater clarity is also required in relation to the scope and remit of the pre-approval audits FSA is proposing to carry out to verify the self-determination of Tier 1 PBOs in practice and to ensure the technical guidance is relevant and fit-for-purpose. This must not lead to disproportionate burdens for developers through potentially open-ended requests for information more usually associated with a risk assessment process, and not currently required for conventionally bred crops or products.  

Similarly, in relation to plants, it is important that information requested by FSA does not duplicate or extend requirements which are already covered by the plant breeding and variety registration process, for example screening for known antinutritional factors such as glycoalkaloids in potatoes or glucosinolate levels in oilseed rape.  

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Indeed, the FSA consultation document refers to existing General Food Law, but does not explicitly acknowledge the role of existing plant breeding and seeds regulations in providing an independent and transparent assurance of the quality and performance of each new agricultural crop variety.

Current regulations on plant variety registration and seeds marketing are proven over many years to support safer and more sustainable food production. Existing statutory arrangements – involving at least two years of field trials and performance, genetic stability and food quality tests – have an impeccable track record of food safety stretching back over many decades.

FSA must also be mindful of the potential impact its statutory information requirements might have on public and consumer perceptions of risk in relation to PBOs, particularly if the information is intended to be included on a public register. The Agency must avoid giving the impression that PB products may have a different risk profile, so need to be treated differently, however well-intentioned and keen it is to be seen to be providing reassurance to consumers.

The bottom line is that wheat is wheat, and barley is barley. If it is acceptable in food safety terms to induce literally hundreds of random and uncharacterised mutations in the genome, as plant breeders have been doing for decades, for example using chemicals or ionising radiation, then it is certainly acceptable to introduce a small number of targeted and well-characterised genetic changes using gene editing techniques.

At this stage it appears that virtually all PB products currently under development would be classified as Tier 1. But that does not mean the Tier 2 category, requiring additional bespoke risk assessment, would necessarily be redundant. The FSA consultation document includes encouraging signals that the Agency is also thinking strategically about future options to streamline the twelve regulated product regimes currently in operation. These include GMOs, whose development remains effectively blocked in Britain by the highly restrictive and burdensome regulatory system we inherited from the EU. Moving to a two-tier system for all regulated products would provide the opportunity for a more case-by-case, proportionate approach to food safety assessment, based on plausible hypothesis of risk rather than formulaic data requirements, such as the 90-day rat feeding studies which are presently required for all GMOs whether relevant to the trait involved or not.          

So, a case of two steps forward, one step back for genetic technologies in the FSA’s current approach.

One final point. It is hugely disappointing that the UK’s much-vaunted precision breeding ‘mission hub’, a £13m research proposal led by the John Innes Centre and involving most of our leading research institutes and universities, has fallen at the first hurdle, not even short-listed for interview by UKRI.

Supported across the value chain, strongly endorsed by Defra and FSA, and touted by Government as an opportunity to establish the UK as a global leader in gene editing in food and agriculture, the cancelling of this project by UKRI must come as a major blow to Ministers who never hesitate to cite the Precision Breeding Act as an example of Britain flexing its post-Brexit regulatory freedoms to drive sustainable innovation and economic growth.

In view of new Defra Secretary Steve Barclay’s recent pledge to ‘tear down the barriers’ to getting ‘game changing innovation’ from the lab onto farm, it suggests that thinking across Government may not be quite as joined up as Ministers would like to have us believe.

Karen Holt is a member of the Science for Sustainable Agriculture advisory group. As a biochemist and molecular biologist, Karen has a long history in the development and regulatory approval of genetically modified crops.  With over 20 years’ experience of biotechnology regulation, she has led many Global projects helping to shape regulatory frameworks as well as being active in OECD and on the Convention on Biological Diversity.  She currently is a consultant in biotechnology regulatory affairs (Holt Regulatory Solutions Ltd) and is also a Fellow of the Royal Society of Biology.

Daniel Pearsall is an independent consultant specialising in communication and policy development in the farming, food chain and agri-science sectors. He runs a small livestock farm in Scotland. He co-ordinates the Science for Sustainable Agriculture initiative. Find Daniel on X @DanielPearsall5

A version of this article was originally posted at Science for Sustainable Agriculture and is reposted here with permission. Any reposting should credit both the GLP and original article. Find them on X @SciSustAg

Viewpoint: ‘I’m not anti vaccine, I’m pro-vaccine safety’ — Debunking Robert F. Kennedy’s lies about vaccine beliefs

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CNN host Kasie Hunt interviewed antivax presidential candidate Robert F. Kennedy, Jr. Although she did better than most journalists confronting him for his past antivax statements in that she played a clip of one of his antivax statements, she clearly hadn’t anticipated his response, which should have been very predictable given that he’s been using it for at least 15 years. I guess it’s time for another primer.

One of the oldest antivax deflections in response to accusations of being antivaccine is a rejoinder of the form “I’m not antivaccine; I’m pro-safe vaccine” or “I’m not antivax; I’m a vaccine safety advocate.” Whatever the exact variation of this particular trope employed by any given antivaxxer when asked if they’re “antivaccine,” the idea is clearly to recast all the negative things that the antivaxxer had been saying about vaccines as not being evidence of a general opposition to vaccines but rather as evidence that they are “vaccine safety” advocates who are just pointing out ways in which vaccines are supposedly insufficiently “safe.” Of course, the antivax definition of “vaccine safety” implied by their attacks on vaccines always involves exaggeration, misrepresenting scientific data, pseudoscience, attributing adverse events to vaccines that they do not actually cause, and the Nirvana fallacy; i.e., a standard for safety that is unreasonable and impossible to achieve in the real world. I’ve written about this particular tactic more times than I can remember going back nearly two decades, but it appears that I need to address it again in the context of an interview conducted earlier this month CNN by Kasie Hunt with antivax activist turned independent Presidential candidate RFK Jr. (a.k.a. Robert F. Kennedy, Jr.).

The reason that I feel compelled to write about this particular antivax trope yet again is because Hunt came so very, veryvery close to handling RFK Jr.’s dissembling perfectly. She fell a bit short, however, because she apparently only anticipated one move ahead, rather than anticipating two or more moves ahead. Don’t get me wrong. As a journalist, she acquitted herself far better than 99% of journalists do when interviewing RFK Jr. However, she fell a bit short by apparently not being prepared for his very predictable rejoinder to being confronted with irrefutable evidence of his past antivax statements. I say “very predictable” because RFK Jr. has been using variations of this response going back to at least 2005.

Let’s take a look at what I mean, and in doing so I’ll show where Hunt did very well, given that the interview involved more than just RFK Jr.’s dissembling about being pro-“vaccine safety,” and where she could have done better. I also do this hopefully as a resource for those who might consider interviewing RFK Jr. in the future. Think of it this way. You can’t win a game of chess by only thinking one move ahead; that is, unless your opponent is a beginner or not very good. Make no mistake. RFK Jr. is not a beginner when it comes to spreading his antivaccine message, and he is actually very, very good at it, having had close to two decades of experience.

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“Not antivaccine, pro-vaccine safety”?

I saw the clip that prodded me to write this post on X, or, as I prefer to call it, the platform formerly known as Twitter:

The entire interview can be found here and:

Note that I wrote about that last conspiracy theory about Ashkenazi Jews supposedly being immune to COVID-19 and SARS-CoV-2, the coronavirus that causes the disease, being an “ethnically targeted bioweapon.” As for being “not antivaccine,” I like to point out how since at least 2014 RFK Jr. has risibly been characterizing himself as “fiercely pro-vaccine,” even as he spews obvious antivaccine misinformation. However, let’s take a look at what RFK Jr. said in the clip played after he had denied being “antivaccine”:

FRIDMAN: You’ve talked about that the media slanders you by calling you an antivaxxer. And you’ve said that you’re not anti-vaccine, you’re pro-safe vaccine. Difficult question: Can you name any vaccines that you think are good?

KENNEDY: I think some of the live virus vaccines are probably averting more problems than they’re causing. There’s no vaccine that is, you know, safe and effective.

Although I’m generally not a fan, I nonetheless give Lex Fridman some credit for asking this question, but he, too, probably wasn’t adequately prepared for a lawyer as lawyerly slippery as RFK Jr. has long been. Personally, I would have followed up by asking specifically which live virus vaccines that RFK Jr. thought were “probably averting more problems than they’re causing,” which would likely have provoked more dissembling given that RFK Jr. never wants to be caught saying anything good about vaccines except as a prelude to trashing them, and would have asked him how saying that there is “no vaccine” that is safe and effective is not antivaccine, which is what Hunt, to her credit, did:

“So, you did say it. Do you still believe it?” Hunt asked again.

“Here’s what I would say,” Kennedy responded. “First of all, I’m not anti-vaccine — ”

“How is that statement not anti-vaccine?” Hunt interrupted.

“Well, I can say right now there’s no medicine for cancer that’s safe and effective. It doesn’t mean I’m against all medicines.”

That bit about cancer medications is a new one—or at least one that I don’t recall having heard him say before—and I’ll deal with it in a moment. First, I note that it wasn’t long before RFK Jr. went back to his old favorites:

I’ve been fighting 40 years to get mercury out of fish. Nobody calls me anti-fish. What I want are vaccines that are proven safe. And, what I meant, which was a bad use of words, is, none of the vaccines that’s currently on the mandated schedule for children, the 72 vaccines, have ever been studied in a pre-licensing safety study. What that means is, we do not know what the risk profile is for those products, and you cannot prove or say with any scientific certainty that those products are causing —

I’ll also get to the part about the “72 vaccines” supposedly never having been studied for safety in a moment, because that’s a more recent “classic” antivax trope that RFK Jr. has been repeating and that Hunt should have expected. I will also point out that RFK Jr. left out one of his old favorites, which was to compare himself to Ralph Nader and his crusade for automobile safety and ask rhetorically (with a flourish, of course) something along the lines of, “Does that make Ralph Nader ‘anti-car’?”

I will also point out that the “I’m not ‘antivaccine,’ I’m pro-safe vaccine” or “pro-vaccine safety” was a favorite antivax rejoinder back in the heyday of Jenny McCarthy 15 years ago. She would routinely employ some variation of this trope whenever she was asked about charges that maybe—just maybe—she might be “antivaccine,” for example, as she did in this interview in 2010 on PBS Frontline:

We’re not an anti-vaccine movement. We’re pro-safe-vaccine schedule. Until we have that conversation, people are going to think it’s an anti- and pro- side.

And:

I don’t think there is a green vaccine. The purpose in our statement of Green Our Vaccines really is: Let’s take a look at our environment. Let’s take a look at some of these toxic ingredients and pull them out. Let’s take a look at a safer schedule. I mean, our motto was “Too many, too soon” with the Green Our Vaccines march. And like I said, it’s not like I’m looking for a Whole Foods version of a shot. We’re looking for just a smarter and safer one in that title of Green Our Vaccines.

I could go on and on and on with examples of Jenny McCarthy using variations on this theme of donning the mantle of “vaccine safety” as though it were the invisibility cloak in the Harry Potter novels, except that she seemed to think that claiming to be “pro-safe vaccine” rendered her past antivax statements invisible. Before I move on I will, however, quote perhaps her most famous example of this tactic, which comes from interview published in TIME Magazine in 2009:

I do believe sadly it’s going to take some diseases coming back to realize that we need to change and develop vaccines that are safe. If the vaccine companies are not listening to us, it’s their fucking fault that the diseases are coming back. They’re making a product that’s shit. If you give us a safe vaccine, we’ll use it. It shouldn’t be polio versus autism.

And:

People have the misconception that we want to eliminate vaccines. Please understand that we are not an antivaccine group. We are demanding safe vaccines. We want to reduce the schedule and reduce the toxins. If you ask a parent of an autistic child if they want the measles or the autism, we will stand in line for the fucking measles.

This is, of course, a familiar false dichotomy favored by antivaxxers. It is also a straw man definition of “antivaccine.” However, let’s get back to the common antivax claim to be for “vaccine safety” and not against vaccines. One way I like to respond to such claims is to ask something along the lines of, “If, as you say, vaccines don’t work, are dangerous, and contain lots of horrible toxins, why on earth wouldn’t you be antivaccine? If I were to come to believe all the horrible things you say about vaccines, I would become antivaccine.” They never seem to have an answer for that one.

Remember how I said that the antivax definition of a “safe” vaccine is deceptive and unrealistic? Notice how McCarthy, even as she was claiming that she was for “safer” vaccines,” was spewing a favorite antivaccine talking point that claims that there are all sorts of horrible “toxins” in vaccines. (There aren’t at the amounts used in actual vaccines.) Back in the day, for example, she used to complain about formaldehyde, which is present in vaccines in tiny amounts left over from the manufacturing process and which is produced in normal metabolism in amounts far greater than what is in any childhood vaccine. In the age of COVID-19, mRNA with pseudouridine, lipid nanoparticles, and tiny amounts of DNA fragments left over from the manufacturing process are the new formaldehyde. What RFK Jr. did in his interview with Kasie Hunt was no different than what Jenny McCarthy was doing in her heyday as the celebrity face of the antivaccine movement.

Coming back to RFK Jr.’s analogy to cancer medications, RFK Jr. was obviously invoking the Nirvana fallacy yet again, in which any medication, particularly any vaccine, that is not absolutely 100% safe and 100% effective is, to antivaxxers, dangerous toxin-laden sludge and utterly ineffective and dangerous. Remember, however, that “safety” is always a relative term in this context. In the case of cancer, more risk of complications and side effects is tolerated because cancer is a life-threatening disease. Viewed in that light, there are a number of very effective ant-cancer medications and chemotherapies that, when you balance the benefits of their efficacy versus the risks of their toxicities, come out with a profile sufficiently favorable to merit the shorthand of being “safe and effective.,” because when we say “safe and effective” we mean safe and effective relative to the indication for which the drug is being used. Also notice how RFK Jr. equates vaccines with cancer chemotherapy. Lawyer that he is, he knows that most people are aware of the toxicities of chemotherapy and, whenever chemotherapy for cancer is mentioned, probably can’t help but think of cancer patients who have lost their hair and look gaunt and unhealthy, either having seen a family member go through cancer treatment or encountered media depictions of what cancer treatment is like. When RFK Jr. glibly says that there are no “safe and effective” cancer medications but that that doesn’t mean that he’s “against all medicines,” he is engaging in sophistry and a false comparison designed to lead the listener to think of vaccines and chemotherapy as having similar levels of risk.

Vaccines, of course, are designed for an entirely different purpose than a cancer treatment. In general, they are designed to prevent, rather than treat, disease. Given that purpose, they are indeed held to a much higher standard of safety, in which a much lower incidence of side effects and adverse events can be tolerated. It would be completely unreasonable to market a vaccine that has a side effect profile like chemotherapy as a disease preventative, which is why vaccines are held to such high safety standards, the efforts of slick liars like RFK Jr. to portray them otherwise notwithstanding. It’s a warm-up for him then to portray existing vaccines as unsafe and ineffective, including his lie that the “72 vaccines” on the childhood schedule have never been tested for safety.

This brings us back to the rest of the exchange, in which Hunt interrupted RFK Jr. as he was claiming that we can’t “say with any scientific certainty that those products are causing —” in order to ask:

“So, you’re saying that you still believe that no vaccines are safe and effective?”

“No! What I’m saying is, none of the 72 vaccines has ever been tested in a safety study.”

Here we go again, and I’ll get to this in a moment, after noting that this statement lead Hunt to ask:

So let me ask you, if you think it’s wise for people to take these vaccines, because you had this to say on a different podcast about whether people with young babies should be getting them shots.

Which led to an image of RFK Jr. over a clip of him saying:

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I love how RFK Jr. claims that he’s never told parents not to vaccinate, even after having said this. Does he think that audio and video disappear? The Internet is forever.

This serves as well as anything as a good segue to RFK Jr.’s claim about “72 vaccines” in the childhood schedule that have never been tested for safety.

72 vials of vaccines on the wall, take one down, give it to kids…

After the audio clip of RFK Jr. saying that he encouraged parents not to vaccinated and expressing the hope that, if enough people tell parents not to vaccinate their children, they’ll listen, RFK Jr. pivoted to:

But what I say again is I had three vaccines when I was a kid and I was fully compliant. My kids got 72.

The whole “72 vaccines” thing is another old and favorite antivax trope, in which they add up every dose of a vaccine that children get, including the yearly flu vaccine and counting each antigen in multivalent vaccines (ones with more than one antigen, like DTaP and MMR) as a whole vaccine, the idea being to come up with a number as large as they possibly can in order to frighten parents. Also, RFK Jr. was born in 1954. In the early 1950s, there were four vaccines available: diphtheria, tetanus, pertussis and smallpox. (To this the Jonas Salk’s polio vaccine was added in 1955.) Because three of these vaccines were combined into a single shot (DTP), children received five shots by the time they were 2 years old and not more than one shot at a single visit. I rather suspect that RFK Jr.’s telling is a bit off. Even so, note that his assumption is that more vaccines are inherently bad and that times were better when children only received a handful of vaccines back when he was a child. I’d have been tempted to ask RFK Jr. which three vaccines he got, which Hunt did, later, asking “What were your three vaccines?” (Again, kudos for that, although it would have been better to ask it immediately, rather than letting him get started on a rant not unlike the one Bluto did when he asked near the end of Animal House whether it was “over when the Germans bombed Pearl Harbor.”)

It was a question that RFK Jr. dodged:

Let me let me finish this. And the there was a gold rush and a vaccine schedule, including a lot of vaccines that aren’t not for diseases that are not even casually contagious.

To which Hunt interjected, reasonably enough, “Name one,” leading RFK Jr.’s antivax rant to continue:

Hepatitis hepatitis B.

Hunt responded, “So you don’t think hepatitis B vaccine is progress?”

Predictably, he doesn’t:

I don’t think that hepatitis B, I don’t think the current, I think the current science suggest that the current hepatitis B vaccines are causing more problems than they’re solving and listen, why would you_

To which Hunt interjected:

I’m not in a position to argue with you. I would do science, but I’m glad you’re on the record as saying that.

From my perspective, that’s one area of weakness that she showed, which allowed RFK Jr. to continue his rant, full of the usual antivax talking points about the birth dose of the hepatitis B vaccine. I’m just going to say that there are excellent scientific, medical, and epidemiological reasons to give a dose of hepatitis B vaccine at birth, RFK Jr.’s rants about giving the vaccine to infants when the disease can only be caught “through sexual interactions or using a needle.” When Hunt says that she “wouldn’t object to it, RFK Jr. then goes off on a quack rant:

But why give it to a whole generation? You know, good health comes from building a strong immune system. And we had we never had hepatitis B epidemics when I was a kid. We never had rotavirus epidemics. A lot of these these products were added to this schedule because they enriched the companies. And this is automatic booking, an automatic windfall, a company now being they’re now allowed to mandate their product with no legal liability.

Never had rotavirus epidemics? Let’s just quote the CDC here:

In the prevaccine era, an estimated 2.7 million rotavirus infections occurred every year in the United States and 95% of children experienced at least one rotavirus infection by age 5 years. Rotavirus infection was responsible for 410,000 physician visits, more than 200,000 emergency department visits, 55,000 to 70,000 hospitalizations, and 20 to 60 deaths annually in children younger than age 5 years. Rotavirus accounted for 30% to 50% of all hospitalizations for gastroenteritis among children younger than age 5 years; the incidence of clinical illness was highest among children age 3 to 35 months.

In other words, either RFK Jr.’s memory is selective, or he is lying. Take your pick.

The rest of the rant is nothing more than a standard longstanding antivax talking point about the Vaccine Court, which was established by the National Childhood Vaccine Injury Act of 1986 and is funded through a tax on each dose of vaccine. Moreover, all the NCVIA of 1986 says is that liability claims for injury due to vaccines have to go through the Vaccine Court first. Federal court is still available to parents if the Vaccine Court rules against them. Moreover, unlike most federal courts, parents who bring complaints to the Vaccine Court will have their reasonable legal expenses reimbursed, win or lose, and the Vaccine Court actually bends over backwards to be fair to parents, to the point of sometimes even compensating them for “injuries” that vaccines do not cause, such as when the court initially ruled to compensate parents who thought that vaccines had caused sudden infant death syndrome (SIDS) in their child. RFK Jr. is a lawyer. He must surely know that what he’s peddling is bullshit. (If he doesn’t, then he’s an incompetent lawyer.)

Also, his kids most definitely did not get “72 vaccines.” RFK Jr., which brings me to another deflection trope that RFK Jr. likes to use when asked if he’s antivax, namely bragging about how he had all his children vaccinated according to the CDC recommended scheule. To this, I note that his five children were born in the years 1984 to 2001, two in the 1980s, two in the 1990s, and one in 2001, the last of which was four years before RFK Jr. “came out” as an antivaxxer. Now compare RFK Jr.’s claim that his children received “72 vaccines” to the actual CDC-recommended vaccines during that time period. (Seriously, it’s not hard to find the history of the vaccine schedule.) From 1980 to 1994, the CDC-recommended vaccine schedule included Diphtheria, Tetanus, Pertussis, Measles, Mumps, Rubella, Polio (OPV), and Hib. By 2000, the schedule included Diphtheria, Tetanus, Pertussis, Measles, Mumps, Rubella, Polio (IPV), Hib, Hepatitis B, Varicella, and Hepatitis A, to which in 2005 the CDC added seasonal influenza vaccines and the pneumococcal vaccine. Note that measles, mumps, and rubella vaccines were administered as the combination vaccine MMR and that before the 1990s the diphtheria, tetanus, and pertussis vaccines were administered as the DTP, which later became the DTaP, which contained the same three vaccines, except that the whole cell pertussis vaccine had been replaced with acellular pertussis vaccine. Let’s just put it this way: There’s no way any of RFK Jr.’s children, not even the one born in 2001, got “72 vaccines,” despite RFK Jr. claiming:

The current recommendations are, I think, around 77 and I have a vaccine record for my child and there are not 77, 70, 77 dose. There are 72 doses of 16 vaccines. Oh, that’s just a fact.

One wonders why RFK Jr. doesn’t actually show the vaccine record for his child, presumably his youngest, who was born in 2001. Let’s take a look at the recommended vaccine schedule for 2000:

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Add it up!

Even using RFK Jr.’s deceptive method of counting multivalent vaccines like MMR and DTaP as three each (because they contain three different vaccines), the most “doses” of vaccine that I can come up with is 40 given in 24 total shots, way short of RFK Jr.’s claim. Seriously, people. This information is not difficult to find. Even if you use the 2005 CDC-recommended schedule and RFK Jr.’s deceptive method, the number of total vaccine “doses” only goes up by a few. Moreover, even if you accept RFK Jr.’s method of coming up with the highest number of vaccine “doses” that you can, so what? Nowhere does he demonstrate that the vaccine schedule, which is science-based, causes harm. Indeed, as Dr. Paul Offit and other vaccine advocates like to point out, thanks to more precise design of modern vaccines, even though the number of vaccines has increased, the number of antigens in the vaccine schedule has decreased markedly, as our friend Skeptical Raptor has pointed out:

Although the current routine childhood vaccine schedule contains more vaccines than the schedule in the late 1990s, the maximum number of antigens that a child could be exposed to by 2 years of age in 2013 is 315, compared with several thousand in the late 1990s. For example the older whole-cell pertussis vaccine contained over 3000 different antibodies, whereas the new acellular vaccine, a part of DTaP, contains fewer than 6.

Basically, RFK Jr. is parroting a common antivax claim that he helped pioneer that children receive way too many vaccines too soon, supposedly overwhelming their immature immune systems. It’s utter BS, and reporters should know that whenever he trots out this trope, as he does quite often and has been doing for two decades. There’s no excuse not to be aware of it.

RFK Jr. did ultimately say:

I would be against mandates at all, for any vaccines, for any vaccine.

But he never answered which three vaccines he got as a kid; instead, Hunt pivoted to the war in the Middle East and discussing RFK Jr.’s claim over the summer that SARS-CoV-2 is an “ethnically targeted bioweapon.” I’ve written a whole typically long post about this conspiracy theory, and RFK Jr. does nothing more than repeat it, but more carefully in order to make himself seem less bonkers. So let’s move on to his other key lie.

Vaccines are not “safety tested”? Nonsense!

Again, Hunt did much better than at least 95% of journalists who interview RFK Jr. do when he starts doing his antivax Gish gallop, but she missed a big one, namely his claim that vaccines are not “safety tested” before release. You might hear that claim and wonder, “WTF?” You’d be correct to do so, because this false claim relies on a very specific, very narrow definition of “safety testing” that I’ve written about before. Let’s circle back to exactly what he said, because he was very lawyerly, very careful about how he phrased his claim that “none of the vaccines that’s currently on the mandated schedule for children, the 72 vaccines, have ever been studied in a pre-licensing safety study.”

One might wonder what RFK Jr. means by “pre-licensing safety study.” One key word is “pre-licensing.” He therefore means the testing done on vaccines before the FDA approves them for their intended indication and the CDC recommends adding them to the vaccine schedule. He does not mean all the post-licensure vaccine safety monitoring systems out there, such as the Vaccine Adverse Events Reporting System (VAERS), a passive monitoring system, and active monitoring systems such as Vaccine Safety Datalink (VSD). Contrary to the way that antivaxxers like to try to abuse VAERS, a lot of resources and effort are used to mine the data in VAERS and VSD for signals that might indicate a safety problem with individual vaccines.

He therefore must mean the clinical trials required by the FDA before approving vaccines—and other pharmaceutical and biologicals—for licensure, specifically the phase 3 randomized controlled clinical trials carried out before a vaccine is licensed. So, just what the heck does he mean? This is really the only area where I have significant criticism of how Hunt handled it. I would have asked, “Wait a minute. What do you mean when you say that none of these vaccines has ever been studied in a pre-licensing safety? What about the large phase 3 randomized controlled clinical trials that the FDA requires to approve a new medication or vaccine?” Had she done that, I rather suspect that it would have quickly become apparent that what RFK Jr. really means when he says that “none of the vaccines that’s currently on the mandated schedule for children, the 72 vaccines, have ever been studied in a pre-licensing safety study” is that they haven’t undergone testing in a double-blind randomized clinical trial (RCT) controlled using a saline placebo.

Again, I recently wrote an entire long post (as have others) about why this claim is deceptive and doesn’t mean that vaccines are unsafe or even that they’ve never been “safety tested,” it’s worth doing the Cliffs Notes version about why this claim is deceptive BS:

  • Ethics. In the event that a safe and effective vaccine already exists and is considered the standard of preventative care for a given disease (e.g., measles), it is unethical to do a double-blind saline controlled clinical trial for that vaccine, because such a trial would require intentionally causing harm by randomizing children to a group that is left unprotected against that disease. There would be no clinical equipoise, which is defined as a genuine uncertainty over which group will do better or worse in an RCT, a non-negotiable ethical requirement for a clinical trial to be considered ethical to carry out. For such vaccines, the appropriate comparator is not saline, but the existing vaccine using a design that can show at least non-inferiority. Dr. Paul Offit called this gambit the “casual cruelty of placebo-controlled trials,” and he was quite correct. Of course, antivaxxers like RFK Jr. don’t care about unnecessarily exposing the control group of such a study to disease.
  • Vaccines have been tested in saline-controlled RCTs. Unlike the case for a vaccine against a disease for which safe and effective vaccines already exist, for a new disease (like COVID-19) or a disease for which no approved vaccine yet exists, the appropriate RCT is an RCT in which the new vaccine is compared to saline. Moreover, if you look at diseases for which there already are vaccines and go back in time, you will nearly always find that the first vaccine against that disease was tested against an inert placebo like saline.
  • Saline and water are not the only scientifically valid placebos for RCT design of an injectable. As I discussed in my post on the subject, there are a number of scientifically valid designs for RCTs that do not involve having an “inert” placebo as a control. Indeed, for vaccines, often the best design is to use as a placebo a formulation that has everything that is in the vaccine normally other than the antigen, to make it as close to indistinguishable from the real vaccine as possible. Yes, that can mean including adjuvants, such as aluminum.

I’ll conclude this section by quoting Dr. Offit on why RFK Jr.’s misunderstanding safety testing and clinical trials is “casual cruelty,” using the original massive RCT used to demonstrate the efficacy and safety of the Salk polio vaccine:

The casual cruelty expressed by ICAN’s lawyer can also be found in an event that occurred almost 70 years ago. In 1954, 420,000 first and second graders in the United States were inoculated with Jonas Salk’s inactivated polio vaccine; 200,000 were inoculated with salt water. It was one of the largest placebo-controlled trials of a medical product in history. Jonas Salk didn’t want to do it. He couldn’t conscience giving a saltwater shot to young children when as many as 50,000 were paralyzed by polio and 1,500 died every year. When the trial was over, the vaccine was declared “safe, effective, and potent.” Church bells rang out; synagogues held special prayer meetings; department store patrons stopped to listen to the results of the trial over loudspeakers. How did we know that Jonas Salk’s polio vaccine was effective? We knew because 16 children died from polio in that study—all in the placebo group. We knew because 34 of the 36 children paralyzed by polio in that study were in the placebo group. These are the gentle heroes we leave behind.

I suspect that none of the parents who volunteered for Jonas Salk’s polio vaccine trial were hoping their children were in the placebo group.

RFK Jr.’s obstinate, unethical, and unscientific insistence that the only valid pre-licensure safety testing of a vaccine is a double-blind, saline placebo-controlled clinical trial, would, if instituted as FDA policy, require that this sort of casual cruelty to be repeated again and again and again—unnecessarily so in the vast majority of cases. It’s important to remember that when RFK Jr. claims that vaccines are not “safety tested,” he has a very specific and scientifically unsupportable definition of “safety testing.”

Kasie Hunt did way better than average with RFK Jr., but journalists need to do better still

One advantage of having paid attention to the antivaccine movement for a quarter of a century and RFK Jr. for nearly two decades is that I have become familiar with all the longstanding antivax tropes and recognize them when I see them. Moreover, I can recognize them when they show up under different guises, a skill that came in very handy during the COVID-19 pandemic, as old antivax tropes were resurrected in new protean forms. I don’t expect reporters, particularly political reporters, to have that deep well of knowledge, and I thought that Hunt did do a fine job, generally. My main purpose in writing this was to highlight how doing a fine job isn’t good enough with RFK Jr. now that he’s running for President and commands more and wider media attention than he ever has before.

Unfortunately, with RFK Jr. running for President and raking in all sorts of cash that will make it impossible to ignore him, anticipating just what he will answer in an interview in response to a question and being ready with clips to bring home the evidence are not enough. You have to think two or three moves ahead at least, and doing that requires developing a deep knowledge of the antivaccine claims that he’s been making since at least 2005 and then using that knowledge every time he tries to deny being antivaccine.

David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. Find David on X @gorskon

A version of this article was originally posted at Respectful Insolence and has been reposted here with permission. 

Analysis: Climate activists issue scare-warnings of impending starvation, but they ignore technology’s future role in scaling productivity

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In 1968, the American scientists Paul and Anne Ehrlich published The Population Bomb. In it, The Ehrlichs foresaw widespread death and despair as global populations—especially in the lower-income countries of South Asia and Sub-Saharan Africa—grew beyond the “limits” of global agricultural output.

The Ehrlichs were wrong. Populations continued to expand over the second half of the twentieth century, but so did agricultural output. And while global temperature has increased by over a degree celsius since 1970—a reality that the Ehrlich’s would likely have suggested would lead to even worse famines—the past half-century has been the most food secure in recorded human history.

As incorrect as he might have been in 1968, Paul Ehrlich has remained an influential voice for environmentalists, population control advocates, and doomsayers who make similar predictions about humanity’s inability to continue to feed itself. On the 50th anniversary of The Population Bomb in 2018, Ehrlich restated his lifelong thesis, now with the addition of climate change, arguing in the academic journal Sustainability that “overpopulation” threatened to trigger future starvation.

While Ehrlich’s focus on population control as a solution to the supposed limits on global agricultural output has gone out of fashion, the most strident climate activists still like to warn of impending starvation at the hands of future climate change. Like Ehrlich, these activists point to climate change modeling that shows declining agricultural yields due to temperature increases, drought, and extreme weather as evidence of their claims. But these claims miss an important point—the same one that Ehrlich failed to recognize and that most major studies pointing to impending disaster ignore, too.

Although climate change may very well reduce agricultural productivity compared to a world without climate change, there is no reason to believe that impact can’t be completely negated due to technological developments.

For many activists—and some scientists and modelers—letting go of the narrative that climate change will lead to starvation may seem dangerous. Without it, the pressure on governments, corporations, and individuals to respond appropriately to climate change may seem diminished. But these false premises are unnecessary to motivate proper responses to climate change when there is an already-long list of real and legitimate reasons to act on climate change. They equally risk attracting investment and focus to low-priority areas of climate mitigation or adaptation at the expense of more pressing, and more scientifically certain challenges, brought about by both climate change and the plethora of other drivers of food insecurity—geopolitical, socioeconomic, and more.

Getting policy right requires clearly articulating the challenges and needs related to climate mitigation and adaptation. For agriculture, that means investing in and prioritizing increasing agricultural productivity globally through the development and adoption of new and proven technologies and practices where productivity lags. Mitigating the climate impacts of agriculture will be crucial; food production and consumption is responsible for roughly one-quarter to one-third of global emissions. But so, too, will be making sure that agricultural productivity growth continues, and that society does not give in to false millenarian models of agricultural decline.

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Climate change’s impact on yields

There have been hundreds of studies and thousands of simulations published in the last several decades on the effects of climate change on agriculture. These studies encompass a very wide diversity of data sets, methods, models, predictor variables, and target variables. The most common study design looks at measures of temperature and precipitation over the growing season and their relationship with yields (e.g. tons per acre) of staple crops like maize, rice, soybean, and wheat.

A major challenge for understanding the influence of environmental conditions on yields is that the variation caused by long-term change in these conditions can be overwhelmed by that caused by technological and socioeconomic factors. Thus, studies attempting to quantify the impact of climate change on agricultural productivity must tease out the relationship in a context of many other confounding factors that can have a much larger influence.

Studies take a range of approaches to deal with these challenges, and find a large range of results. One major global study that looked at crop yields from 1974 to 2008 indicated a wide range of responses of yields to climate change depending on the location and the crop but found a global net 1% decrease in consumable food calories of 10 major crops relative to a hypothetical world without climate change.

Another recent major study, though, indicated that a range of potential warming and enhanced CO2 levels will actually increase global wheat, rice, and perhaps soybean yields and decrease maize yields (See Figure 1).

Figure 1: Projections of Global Crop Productivity for the 20th Century

image prvw
Note: a, Productivity time series for maize, wheat, soybean and rice shown as relative changes to the 1983–2013 reference period under SSP126 (green) and SSP585 (yellow). Shaded ranges illustrate the IQR of all climate–crop model combinations (5 GCMs × 12 GGCMs). The solid line shows the median response (and a 25 yr moving average). Horizontal dashed lines mark the standard deviation of historical yield variability and model uncertainty (that is, ‘noise’ from individual climate–crop model combinations) and open circles highlight the Time of climate impact emergence (TCIE, the year in which the smoothed climate change response emerges from the noise. b, Maps showing median yield changes (2069–2099) for maize, wheat, soybean and rice under SSP585 across climate and crop models for current growing regions (>10 ha). Hatching indicates areas where <70% of the climate–crop model combinations agree on the sign of impact. c, Regional productivity time series stratified for the four major Koeppen–Geiger climate zones (temperature limited, temperate/humid, subtropical and tropical). The percentage of the total global production contributed by each zone is indicated in the top right corner of the insets. CO2 fertilization is included. From Jägermeyr, J., Müller, C., Ruane, A.C. et al., 2021. Figure S3.

Most studies, however, tend to find that, on a global level, climate and CO2 changes are detrimental to yields. Meta analyses synthesized by the IPCC report that, since 1960, climate and CO2 change have decreased yields for wheat by 4.9%, maize by 5.9%, and rice by 4.2% relative to a hypothetical world without climate change since 1960.

But even these estimated impacts look small when you place them in the context of large background yield growth (See Figure 2).

Figure 2: Influence of climate change on crop yields in the context of background yield growth 1961-2020

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Note: Originally from Breakthrough Institute analysis.

Agricultural productivity growth in the face of climate change

Over roughly the past half-century, the world has warmed about 1 degree Celsius, and yet global agricultural output has increased almost four-fold. Global total factor productivity, a measure of overall efficiency (i.e., agricultural output divided by total inputs like fertilizer) increased by 79% over the same period. And while global land-use for agriculture increased by 25%—from just over 1.7 billion hectares in 1970 to just under 2.2 billion hectares today—without the increased yields made possible by technological advancement, a further 3.1 billion hectares of land could have been converted. In other words, even with small productivity losses compared to a hypothetical world without climate change, yield gains during that period saved just under a quarter of the world’s total arable land from agricultural expansion.

The productivity gains that prevented further agricultural land expansion were mainly due to the dramatic increases in agricultural yields since 1961. For example, global maize yields increased by 196%, wheat by 218%, and rice by 147% (Figure 2).

Productivity gains didn’t just save land, they saved people. Increased global agricultural output has meant decreased food insecurity. Global per capita calorie availability—a measure of total food supply—has risen from 2357 kcal per day in 1970 to 2947 kcal in 2020, a 25% increase. Since 1970, according to the FAO, there has been a decline in the prevalence of hunger in lower-income countries by almost two-thirds; whereas 34% of the global population faced hunger in 1970, just 13% did in 2015. From 1870 until the 1970s, famines killed approximately 900,000 people each year, while from the 1980s onwards, the average annual death toll of famines decreased to about 75,000 people each year.

While the increase in global temperature over the past half-century did cause decreases in agricultural productivity, the net productivity growth over that period was nothing less than massive. The fact that the detrimental impact of global warming has been totally overwhelmed by technological and socioeconomic advances leads to a predicament for making projections going forward. The easiest and cleanest study design is one where the multifactorial impacts on yields are held constant except for climate change. The benefit of this is that a researcher does not have to speculate on unpredictable socioeconomic dynamics that affect the adoption of current best practices or attempt to predict future technological advancement.

However, there is no reason to believe that technological and socioeconomic forces will suddenly stop impacting agricultural yields, or that the many other factors that come to bear on hunger—geopolitics and economic interdependencies, for example—will become unimportant.

Studies like the UN Food and Agricultural Organization’s Future of Food and Agriculture (FOFA) analysis have attempted to account for these multifactorial impacts. FOFA looks at climate change as one of eighteen “critical drivers” of agricultural transformation to appraise future food system scenarios. Accounting for these factors, the FAO projects a business-as-usual 50% increase in global agricultural production by 2050.

Some might be tempted to think that the problem is, then, solved. But here, a look at the historical drivers of agricultural productivity and yield growth points to some real challenges.

The past half century’s gains were mainly due to massive productivity growth in places like the United States, Western Europe, and parts of South America, East Asia, and South Asia. While agricultural yields and productivity have increased in Africa, Central Asia, and other relatively low-productivity agricultural regions, growth rates have been slower, and the starting points were lower.

For example, while North American agricultural total factor productivity approximately doubled between 1970 and 2020, Sub-Saharan Africa’s agricultural productivity only saw a roughly 16% increase. According to USDA data, that figure has declined slightly since 2015.

Similarly, whereas global average per capita calorie availability has increased to match North American food supply of 1970, Africa today has a per capita caloric availability—about 2500 kcal—closer to the 1970 global average. And while global hunger, measured more broadly, has decreased precipitously since 1970, food insecurity and malnutrition remain critical issues in regions with lower agricultural productivity. A 2022 UN World Food Programme report highlighted 19 “hunger hotspots,” all of which were either regions currently in conflict or where agricultural productivity has been relatively stagnant.

Catching up to 20th century agriculture: Mechanical, irrigated, fertilized

In the United States, as well as in many other high-income countries, the middle decades of the twentieth century saw world-beating productivity growth. The adoption of labor-saving mechanical equipment – tractors, reapers, and the like – drastically reduced the need for farm labor inputs, while increasing outputs. The use of newer chemical inputs – like fertilizer and pesticides – in the decades immediately following World War II drove drastic crop yield increases. And the large-scale consolidation of farmland, matched by increasing rates of farm specialization altered the agricultural landscape, increasing output and allowing farmers to capitalize on economies of scale.

At the same time, the broader societal, technological, and economic changes that occurred in the years prior to 1970 in higher-income countries – namely electrification, massive infrastructure construction in the form of highways and railways, and large-scale water projects, to name a few – had significant benefits for agricultural productivity growth.

Outside of the U.S., and higher-income countries more broadly, agricultural productivity followed numerous paths over the past half-century. In India, for example, “green revolution” technologies like synthetic fertilizer and hybrid crops drastically improved crop yields but have been criticized for homogenizing Indian agriculture and forcing agricultural laborers off farmland without other options for gainful employment. Countries of the former Soviet Union, like Russia and Ukraine, have taken advantage of fertile soils and large-scale mechanization to increase yields – especially for grain production – without drastically increasing fertilizer use per acre.

For many lower-income countries, agricultural productivity growth came from the uneven adoption of technological equipment and new processes. Many farms in Sub-Saharan Africa, for example, are not irrigated, do not use mechanized equipment, and use only very small amounts of chemical inputs. At the same time, in lower-income countries, agricultural land ownership has remained relatively decentralized, meaning that small-holder farmers have remained the primary user of agricultural land. This limits the capital intensity of agriculture and keeps farms less specialized, as many smallholders produce food for subsistence and for local trade.

Irrigation can allow expanded cultivation in countries with little rainfall and can allow farmers to supplement water from rainfall in dry years, lessening or avoiding crop loss due to drought stress. Irrigated agriculture is twice as productive, on average, as rainfed agriculture, and irrigation has been an important driver for increasing crop yields in many countries. Despite these advantages, irrigated agriculture makes up only 20% of global cultivated land, with uneven distribution. Sub-Saharan Africa, for example, has the lowest percentage of irrigation on arable land at 4%, while Latin America has 14% irrigated land, and Asia boasts 37%.

Although irrigation can increase agricultural productivity, it can also contribute to water scarcity. However, high-efficiency targeted irrigation technologies like drip lines can dramatically reduce water wasted due to inefficient application. At the same time, regular maintenance of existing irrigation systems is necessary to reduce water wasted due to leaks. Globally, agriculture accounts for 70% of all freshwater withdrawals, and water-saving irrigation technologies are especially important in regions with high levels of water stress, such as the Middle East, North Africa, and South Asia.

But irrigation often cannot simply be the choice of individual farmers. Building out the necessary infrastructure to increase the number of acres irrigated across lower-income countries requires government intervention, and risks creating political and social tension about water projects—for example, dam construction—and water use.

More broadly, for farmers in lower-income countries to adopt the many existing technologies and practices that make modern agriculture so productive will require government intervention, flexible financing, and the right incentives. For example, while almost all farms are mechanized in places like the United States, tractors and other labor-saving and productivity-boosting mechanical equipment remains underutilized in lower-income countries. In 1900, farmers in the United States relied on 21.6 million work animals; by 1960 (the last year work animal data was collected by the U.S. Census) only 3 million work animals were being used by American farmers, who had turned instead to 4.7 million tractors. Today, few farms in the United States do not use mechanized equipment.

In comparison, smallholder farmers in lower-income countries use tractors and other mechanical equipment at a much lower rate, relying instead on human and animal labor. In 2012, only 2% of Kenyan farmers used tractors, a decline from 5% in 1992. The use of oxen increased over the same period from 17% to 32% of Kenyan farms. Similarly, only 4% of Nigerian farmers used tractors in the rainy seasons between 2010 and 2012. Increasing the uptake of mechanical equipment will be crucial to increasing productivity and yields by reducing labor and improving the timeliness of farm operations, though the impact of cutting farm laborers out of the agricultural economy must be considered.

There is a similar uneven distribution of productivity-enhancing technologies and practices when it comes to chemical inputs. Agricultural producers in high-income countries tend to use significantly more nitrogen and other fertilizers than producers in lower-income countries (Figure 3). For example, while American farmers used an average of 124 kg of fertilizer products per hectare of cropland in 2020, every Sub-Saharan African country, except for Zambia, used less than half of that amount. Countries like the Democratic Republic of Congo, Congo, Niger, and Mali all used less than 10 kg of fertilizer products per hectare in 2020.

Figure 3: Fertilizer use per hectare of cropland, 2020

fertilizer use per hectare of cropland
Source: FAOStat, originally from Our World in Data.

Efforts to increase fertilizer use in Sub-Saharan Africa have been effective at improving yields, but they have been piecemeal due to the high cost of fertilizer. In Nigeria, a fertilizer subsidy program increased yields by 38% between 2010 and 2013 for participating farmers, but cost a significant portion—as much as 26%—of the Nigerian agricultural budget. A similar program in Malawi from 2005 to 2009 increased yields by 42% for producers on average, but cost approximately 16% of the total government budget.

For mechanization and fertilizer use—as well as the myriad other agricultural technologies and practices that remain geographically uneven, like modern pesticides—increasing adoption in lower-income countries is not a simple, no-consequence decision. Mechanization of agriculture reduces the need for labor, effectively cutting some farm laborers out of the agricultural economy. Fertilizer use could have the same consequences and could lead to significant ecological harms if fertilizer is indiscriminately or irrationally used. Broadly speaking, simply transporting technologies and practices from one context to other risks missing local contexts. While the United States and other high-productivity agricultural regions can provide good examples of different pathways to increasing yield and overall productivity in agriculture, the comparisons cannot and should not provide an exact roadmap of technological adoption and agricultural evolution.

In fact, the United States equally provides an example of how not to industrialize agriculture. Nutrient run-off, the marginalization of rural communities, and the monopolization of agricultural input and processing industries are prices that the United States paid for a high-productivity system. Ideally, recognizing these tradeoffs can mean that agricultural productivity growth elsewhere can benefit from the technological breakthroughs that allowed for high U.S. yields, without all the negative tradeoffs that currently define U.S. agricultural production.

Biotechnology and the biological revolution

A central pathway to increasing productivity growth and global agricultural yields is crop genetic improvement. But, few technologies have received the extent of criticism as agricultural biotechnologies. Employing genetically modified and gene edited crops to improve yields globally will require building trust, achieving buy-in from producers and consumers, and moving beyond punitive intellectual property laws. And yet, the necessity of biotechnology to enhance crop genetic improvement is dire.

In the United States, crop genetic improvement has been responsible for about half of historical productivity gains in maize, soybeans, and wheat. By some estimates, further improvements in plant breeding could reduce global agricultural GHG emissions by almost 1 GT CO2e/year by 2050, mainly by increasing crop yields. This estimate includes genetic improvement through conventional plant breeding; newer assisted breeding technologies like marker-assisted breeding and genomic selection; and biotechnology, which is an umbrella term that covers technologies including genetic modification, genetic engineering, GMOs, gene-editing, and CRISPR.

Historical yield gains due to genetic improvement before the 1990s were mainly due to conventional breeding. Conventional breeding—usually defined as crossbreeding, selection, and radiation and chemical mutagenesis—created higher-yielding, stronger, and shorter wheat plants that can hold more grain, and hybrid maize that grows well at higher planting densities. For example, the shift to hybrid maize—which started around 1930—improved yields, with 16% of maize yield gains in Minnesota between 1930 and 1980 due to the transition to hybrid seeds, and 43% to other breeding improvements.

Scientists started using genetic modification (sometimes referred to as genetic engineering or transgenesis) in crop plants in 1983, and the initial planting of genetically modified insect-resistant and herbicide-tolerant crops started around 1995 in the United States. Genetic modification allows for the introduction of a trait from one plant or non-plant species into a crop plant of another species. One global meta-analysis found that between 1995 and 2014, genetically modified insect-resistant and herbicide-tolerant crops had 22% higher yields and 37% lower pesticide use, on average, than non-genetically modified varieties. These benefits are on average greater in low-income countries where existing pest- and weed-management systems are less effective and the potential for improvement is higher. Yield gains are still significant, albeit smaller, in high-income countries. Genetic modification has also been used to create drought-tolerant wheat, which can increase crop yields under stressful conditions in drought years.

Gene editing—most recently through CRISPR—allows scientists to make small, precise changes to DNA. These changes can be indistinguishable from the single-letter DNA mutations that have historically been made at random using chemical and radiation mutagenesis in conventional breeding. However, gene editing is much faster. Gene editing is estimated to reduce the time to introduce a new trait to a crop by nearly two-thirds. For example, in order to add a disease resistance trait to a commercial variety of maize, it could take only 2–3 years using gene editing, compared to 7–8 years using conventional breeding. By another estimate, conventional breeding in maize generally takes an average of 9–11 years to introduce a new variety of crop to market; in comparison, gene editing can take just a few years.

The first two gene-edited crops (high-oleic oil soybean and high GABA tomato) were each introduced to the market about 9 years after the initial publication of each gene-editing technology. Gene editing is also being used to make crops drought tolerant or resistant to problematic diseases.

Tools for plant genetic improvement have become increasingly fast, predictable, and precise compared to conventional breeding or even to the first generation of genetically modified crops. Besides genetic modification and CRISPR gene editing, other new tools like marker-assisted breeding and genomic selection have increased the speed of conventional breeding.

Although biotechnology is not the only contributor to crop genetic improvement, it is an increasingly important component. A greater variety of tools provides flexibility for addressing the constant challenges of pests, diseases, and weeds—all of which are central constraints on yield growth—and continuously improving crop productivity. Compared to slower tools like conventional breeding, faster tools like genetic engineering and genome editing enable more rapid improvement.

But scientific breakthroughs in the technologies underpinning crop genetic improvement are useless for improving the productivity and output of global agriculture if high-quality seeds are not available for the millions of producers who need them. Simply, the supply of high-quality seeds—seeds that have ideal genetic traits, a high rate of successful growth, and are disease free—is a crucial contributor to increasing crop yields.

In higher-income countries, large-scale farms rely on high-quality seeds from certified providers. But in lower-income countries with many smallholder farmers, such seeds are often not available or affordable. Smallholders are left to rely on seeds they or other farmers save from previous seasons’ harvests (often called local cultivars or indigenous varieties), which have more variability in quality and higher rates of disease than seeds from certified providers.

For example, hybrid maize seeds contributed to massive yield gains in the United States in the 1930s and 1940s, but are used less widely in lower-income countries. Hybrid seeds are made by breeding two or more plants with different characteristics to create descendant cultivars that are more productive. Importantly, plants grown from hybrid seed will produce much lower-quality seed in the next generation, requiring farmers to repurchase seed each season to maintain a high-quality crop.

One study across 13 countries in Eastern, Southern, and Western Africa showed an average of 37% of maize area cultivated with hybrids, 21% with other higher-quality seed from certified providers, and 43% with seeds saved by farmers. Even among maize seed from certified providers, studies show that hybrid seeds on average yield 18% or 21–43% more than the best performing non-hybrid seed, making up for the difference in annual cost of seed. A 2017 study found that Kenyan farmers that do plant hybrid maize seed are wealthier than farmers that grow non-hybrids.

The cost of seed is not the sole barrier to farmers growing hybrid crops. Weak extension systems, limited access to produce markets, low profit margins for smallholders, on-farm crop diversity that limits economies of scale for individual crops, and farmer loyalty to specific varieties all reduce the likelihood of farmer adoption of hybrid, or otherwise improved, seed. Private sector programs can overcome barriers to farmer adoption of improved seed but require the capacity to fund agricultural improvements through credit and debt systems. For example, the One Acre Fund provides farmers with improved seed and fertilizer on credit, trains farmers in modern agricultural techniques, and facilitates access to markets.

Innovation and the known unknown

Increasing global agricultural productivity is not just a question of raising yields in places where they are currently low. Novel technologies and continually improved practices must also play a key role in maintaining or increasing yields in higher-income countries.

Historically, agricultural breakthroughs have benefited immensely from the support of public sector research and development (R&D) funding. Public R&D remains crucially important for the maintenance of agricultural yields, but government spending on agricultural research has slowed down or declined in some major economies. In the United States, public agricultural R&D spending measured in real dollars declined by a third from 2000 to 2020.

Agricultural R&D drives productivity growth by spurring innovation. Increasing global agricultural R&D spending, especially public R&D, will be necessary to increase agricultural productivity globally. Analyses by agricultural economists consistently show the high impact of public agricultural research spending. A 2023 study, commissioned by The Breakthrough Institute, found that roughly doubling U.S. public agricultural R&D would increase agricultural output by 69.5% by 2050—about a two-fifths increase over a business-as-usual approach.

And outside of the need for broader agricultural innovation, there are several emerging technologies today that could raise productivity while reducing environmental impacts. Alternative proteins can produce high quality protein from fewer crop calories than conventional livestock agriculture. Precision agriculture can reduce the need for chemical inputs without limiting crop yield. Feed additives for cattle can improve the efficiency of cattle diets, both reducing methane production and helping cattle grow faster.

These new technologies and improved production practices could be significant sources of productivity growth, but their benefits are not necessarily a given. In many cases, these technologies remain in the process of research and development, and their industries lack both the funding and know-how of scaled manufacturing or deployment.

Conclusion

Ensuring food security is a crucial political and social concern. It is more likely than not that climate change will reduce overall agricultural productivity. However, climate change is very unlikely to be the primary driver of global yield changes for the foreseeable future. Instead, agricultural yield growth and overall productivity will continue to be the product of the many factors that have influenced it to date: government investment in research and development, farm programs, infrastructure, shifts in production location, technologies like crop breeding, farm machinery, and chemical or biological inputs, and much more.

We should certainly be concerned about the impacts of climate change on agriculture and seek to mitigate them. Doing so at the cost of funding other important agricultural efforts, however, would only further threaten the hundreds of millions of farmers and food insecure people across the world that depend on increasing global agricultural yields.

Viewpoint: Crop biotechnology opponents are losing their war against genetic engineering but the battle for science is not yet won

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It was not so long ago that the strident opponents of agricultural biotechnology were dictating the narrative over sustainable crops. They promoted lies about their supposed dangers to humans, animal health and the environment — misrepresentations that have poisoned public perceptions about the value of this fast-developing technology.  

To frighten the public, the anti-biotechnology campaigners stigmatized genetically modified (GM) crops as Frankenfoods, the product of out-of-control scientific experiments conducted by nefarious and greedy agri-businesses determined to fatten corporate treasuries, the public and the environment be damned.  One of the most popular symbols used to scare people into opposing GM crops was a syringe injecting a tomato; the implication was that dastardly chemicals were being injected into our food supply. 

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The science rejectionists found eager allies in Hollywood and beyond to promote disinformation. From Dr. Oz. to Jill Stein, Gwyneth Paltrow, Neil Young, Mark Ruffalo, Joe Mercola and Woody Harrelson, celebrities who knew little about science let alone biotechnology climbed on the anti-GM bandwagon, impugning the integrity of scientists; even in 2015, at the height of the hysteria campaigns, 88 % of US scientists endorsed the safety of the technology, higher than the consensus view that climate  is being primarily driven by human activities. The percentage is likely near 100% today.

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Then and even now, a figurative handful of scientists acted as willing fronts for GMO-rejecting advocacy groups. Influential NGOs such as Friends of the Earth, Greenpeace, Environmental Working Group, Union of Concerned Scientists and the Natural Resources Defense Council launched campaigns against agrobiotechnology and crop chemicals. It was cynical, but it proved to be a lucrative fund-raising strategy

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From skepticism to acceptance

After years of reaping the tainted rewards of disinformation, the ground is shifting against anti-crop biotechnology activists with its benefits apparent in agriculture and medicine. Recent advances in agriculture are stunning. Crops are being developed that are disease, drought, stress, salt, insect and browning resistant, more nutritious, colorful, tastier and with longer shelf lives. Among the products of so-called new breeding techniques (NBTs) recently approved for cultivation and sale around the world: heart-heathy soybean oil, late blight resistant, low acrylamide and reduced bruising potatoes, non-browning apples, drought-resistant wheat, insect-resistant cowpeas, which are a major staple crop in west Africa, a purple tomato with increased anti-oxidants and a longer shelf life, mustard greens that are less bitter, a heart-healthy tomato, fish oil made from canola, and pigs that are resistant to Porcine Reproductive and Respiratory Syndrome.

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We are just  at the beginning of the genetic engineering bounty. In the pipeline and likely to be approved in the next few years: non-browning avocados and bananas, disease-resistant bananas, disease-resistant citrus crops, disease-resistant chestnut trees, seedless blackberries and raspberries and pitless cherries, chickens resistant to avian flu, allergy free wheat and peanuts, drought-resistant rice, disease resistant cassava and disease-resistant rice.

The promise of NBTs has become so self-evident that nations long on the genetic modification sidelines are rushing to deregulate the technology to boost farm productivity. One of the most prominent of these is China. After becoming one of the first countries to embrace crop genetic modification in 1993, production stalled for decades as the government equivocated in the face of public opposition, although it did import GM soybeans from the US and South America. Now China is determined to be a global CRISPR innovator. 

In 2022, it announced it was deregulating crop gene editing. Last year, the government preliminarily approved 37 genetically modified corn seeds and 14 GM soybean seed varieties. In January, China authorized the domestic production of six additional varieties of GM corn, two of soybeans, one of cotton, and another two of gene-edited soybeans.

With China opening the door wide to the cultivation of GMOs and the deregulation of gene editing, the top eight most populous countries — China, India, the US, Indonesia, Pakistan, Nigeria, Brazil and Bangladesh —now either grow GMO crops or have approved the deregulation of gene-edited crops. That’s more than 50 percent of the world’s population. 

Food exporting countries are jumping on the NBT bandwagon. Latin America, led by Brazil and Argentina, has long been a crop biotechnology innovator. Cuba has been developing GMO crops for years, and has begun experimentation with gene editing.  Only a few countries — Peru, Belize, Ecuador and Venezuela — seem determined to remain crop technology backwaters.

Africa is gradually opening its doors to crop technology innovation, with GMO laws in place in Nigeria, Ethiopia, Kenya, Sudan, Malawi, Ghana, Zambia and South Africa.  Each of these countries is debating reforming regulations to allow gene-edited crops for import and domestic cultivation. South Africa grows GMOs but has refrained from deregulating gene editing.

India, Japan, Israel, and Australia grow GM crops and recently have deregulated gene-editing for crop production. New Zealand’s new government has indicated it is open to considering deregulating gene editing. 

Perhaps the most consequential change is unfolding across Europe. In March 2023, the UK Parliament deregulated gene editing (although the legislation applied only to England). Last July, the European Commission issued a report outlining a plan to relax the rules and regulations on gene-edited crops. How that debate plays out in coming years will determine whether the EU will emerge as a technology leader or a backwater in agricultural production.

How anti-biotechnology activists lost their battle to ban next-generation engineered crops

First, they cried ‘wolf’ and the sky never fell.

Since the introduction of GM crops in the mid-1990s, opponents have warned that new breeding techniques would have catastrophic consequences for human and animal health, and the environment. We were told that GMOs would cause cancer and infertility, and disastrously corrupt the DNA of those consuming genetically altered crops (ignoring the fact that humans have been ‘corrupting’ the DNA of crops since the dawn of humankind, through wide crosses, hybridization, cloning and mutagenesis). We were warned that GMOs would alter the environment in catastrophic ways. We were lectured that farmers were being brainwashed by global agribusinesses to adopt farming strategies that were against their own and the public’s interests. 

None of these apocalyptic warnings came to pass. You would think that after thirty years since the introduction of GM crops and no credible incident of anyone or any GM-fed animal being harmed by consuming GMO foods, anti-GE crusaders would move on to another cause. Instead, they continue to peddle their nonsense even as their credibility sinks day by day. 

Second, they are technology hypocrites.

Crop biotechnology critics oppose the use of genetic engineering for the cultivation of crops but for the most part endorse their use in medicines and vaccines, even though the processes are similar. GMO insulin was developed decades ago and has been used safely with no public controversy. Highly effective and safe COVID mRNA vaccines are a product of genetic engineering as are other vaccines such as those for Ebola and HPV. Scientists are now utilizing gene editing to develop malaria and shingles vaccines. Authorities in Europe and the US recently approved a gene-edited treatment for sickle cell anemia. More cancer treatments using gene editing are in development.

A positive note: News coverage around the use of gene editing to develop medicines, although not as advanced as its applications in agriculture, does appear to be softening public opposition to genetic innovation. It simply makes no sense to welcome gene editing in health care but oppose it in agriculture.  

Third, opponents of genetic engineering are wrong in claiming that gene-editing deregulation will result in the ‘control’ of global food and seed supply by multinational agri-businesses.

There is scant evidence to support that claim, and much evidence to suggest, that the gene editing revolution is democratizing seed development. Because of the dense and politicized GMO approval process, it takes on average 8-13 years and more than $130 million to get a GMO crop trait approved. 

With gene editing, innovation has been unleashed. It can now take as little as a few million dollars and two years or less to develop a crop with a beneficial new trait. One faculty researcher at Penn State developed an anti-browning mushroom for less than $50,000. 

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There is a plethora of new gene editing-focused companies in the US funded by venture capitalists: Pairwise, Cibus (which merged with Calyxt), Green Venus, Elo Life Systems and Yield 10 Biosciences, to name a few. Some of them, such as Pairwise and Calyxt, have already brought products to market.

Fourth, the challenges of confronting increased disease and weather dislocations caused by climate change make it clear that biotechnology obstructionism is indulgent and dangerous.

We cannot continue to grow food the way we do now. With food demand predicted to soar 50 percent by mid-century according to UN predictions, and with no more large tracts of arable land yet unexploited, we need to produce more crops on less land. Growing less food and/or clear-cutting forests to increase output is a strategy for planetary suicide. Sustainable intensification using genetically tweaked crops is now widely recognized as the only tenable path forward to meet the challenges of climate change-induced droughts, persistent plant diseases, increased insect infestations, worsening soil conditions and shortened growing seasons. 

Fifth, only crop biotechnology offers innovative and scientifically realistic new ways to reduce waste and spoilage.

A significant part of the food shortage crisis results from food waste. Genetically modified crops designed to resist browning and bruising, and spoil far less quickly, could significantly reduce crop waste.

Sixth, only next-generation crops can produce more food with less chemicals.

Insect-resistant and herbicide-tolerant crops have resulted in a net global decrease in the volume of crop chemical applications. A meta-analysis documents that on average, GM technology adoption has reduced chemical pesticide use by 37%, increased crop yields by 22% and boosted farmer profits by 68%. Environmental Impact Quotient (EIQ), which measures the toxic impact of chemicals rather than just volume, has shown a 17.3% decrease between 1996 and 2020, almost all the result of GM crop adoption. And even as crop chemical usage per acre is decreasing in countries that grow genetically engineered crops, food production is soaring.

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Source: https://www.mdpi.com/2071-1050/9/4/580

Gene editing promises even more reductions in chemical usage, including the development of plants that can generate their own nitrogen, thus reducing the need for chemical fertilizers. 

Seventh, anti-crop biotechnology activists are being recognized as scientifically regressive.

Science innovation is quickly passing genetic engineering rejectionists by. Gene editing pioneers in medicine and agriculture are working tougher to educate the public as to the benefits of this emerging technology. Jennifer Doudna, the co-winner of the Nobel Prize for chemistry in 2020 for discovering CRISPR gene-editing, has become vocal in her support for its use for agriculture. And in January 2024, 35 Nobel laureates and more than 1,000 European scientists signed an open letter to the European Parliament urging it to deregulate gene-editing for crops, writing it has the potential to dramatically reduce pesticide and fertilizer use, increase food supply and enhance food security. Most recently, the EU Commission voted to establish a revised system to fast-track approvals of products of New Breeding techniques.

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Innovation vs. Obstructionism — What the future holds for gene editing and other New Breeding Techniques

Although opponents of genetic engineering are in retreat, they remain an intractable and dangerous foe. They are disinformation machines. Their current strategy: to tar and feather CRISPR gene editing and other NBTs with the stigma long associated with what they call Frankenfood GMOs. That’s the term wielded for decades by activists to convince the public that seeds engineered using genetic modification are ‘not natural’ and are therefore unpredictable, risky and dangerous.

Let’s unpack this misinformation trope. How did the term Frankenfood come about and how are current generation science rejectionists using it to scare the public and policymakers?

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For years, biotechnology skeptics grounded their opposition to GMO crops on the premise that the process of creating new crop varieties, known as transgenesis, posed unique and unknown health and environmental dangers. A transgenic, or genetically modified, seed has been altered through recombinant DNA technology, which involves either the combining of DNA from different genomes or the insertion of what is technically called “foreign DNA” into a genome.

The use of the term “foreign” by scientists is not a judgment; it means merely that the DNA is from another living form. Because all life on earth shares DNA, there is technically no such thing as ‘foreign DNA’ as GMO opponents wield the term. Yet, anti-GMO activists have weaponized the term “Frankenfood”, claiming for example that a new and bizarrely dangerous variety of tomato was being created using fish genes.

That’s simplistic, farcical, and a non-scientific framing of the process of genetic modification. Nonetheless, it’s worked its damaging, public relations magic, helping to turn an uncertain public against GM crops. As recently as 2020, a Pew Research survey indicated only 27 percent of Americans believed GMO foods were safe while 38 percent said they were unsafe; 33 percent were not sure. The reason most people cited for being wary of genetic modification: the claim by opponents that the foods are not natural because the seeds were created using genes from a different species–like tweaking tomatoes with fish genes!

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Is there any validity to their claims that GMOs present a unique risk because they use “foreign genes”? And what about the newest generation of GM crops, which use a different breeding technology known as gene editing, which includes CRISPR? 

No crops that we eat today are ‘natural’; all our plant-derived food has been modified over the centuries by human intervention. The corn we eat today consisted of hard black nubs many centuries ago. Seedless watermelons were created by hybrid breeding. An entire genus of edible plants known as Brassica were once inedible weeds; human manipulation has turned the plant into some of our most beloved vegetables, including red and green cabbage, broccoli, cauliflower, romanesco, Brussels sprouts, collards, kales, Savoy cabbage and kohlrabi. 

Genetic modification of crops in laboratories is just a more precise form of plant breeding than what humans have been doing for millennia. Gene editing is the latest tool used by humans. It also does not involve the use of “foreign genes” at all, as changes to the plant genome are made within the species itself, a process known as cisgenesis.

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Click HERE to download the PDF.

From the perspective of a scientist, neither GMO transgenesis nor gene editing cisgenesis is inherently safer or more dangerous; they are just different techniques. It’s absurd that many countries are relaxing regulations on New Breeding Techniques while continuing to shackle the approval process for GM products. 

In an ideal, science-driven world, with overwhelming evidence that both transgenic GMOs and gene-edited crops pose no identifiable unique health or environmental threats, the two complementary breeding techniques would face minimal regulatory hurdles. But we don’t live in that science-shaped world. Sadly, many GMO crops remain in regulatory purgatory as a residue of the Frankenstein branding by anti-biotech activists. In contrast, crops grown from new breeding techniques are quickly being embraced, and regulatory hurdles are falling globally. So, we have the bizarre situation in which many countries, including Nigeria, Israel, England and Japan, that are deregulating gene-editing for crop cultivation, yet they still place stringent regulations on transgenic crops, which pose no more health or environmental hazards. Even while the European Union edges towards de-regulating gene editing, any thoughts of fast-tracking GM approvals remain off the table.

No matter how the public and policy debate plays out, crop biotechnology is roaring forward. In not too many years, the vast bulk of the food we consume will be genetically tweaked using one form of technology or another. Advanced countries will de-regulate crop genetic engineering because it will increase farm productivity and is one of the only available tools to battle the crop-killing impacts of climate change. As a result, we will have many insect, disease, drought, stress and browning-resistant crops that will be tastier, more colorful, more nutritious and have longer shelf lives.

We will eventually look back upon this period of hyped worries and predictions of impending environmental catastrophe and be mystified at what all the fuss was about.     

Steven E. Cerier is a retired international economist and a frequent contributor to the Genetic Literacy Project.

Is Alzheimer’s disease transmissible?

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Five people treated for pituitary dwarfism decades ago with human growth hormone (hGH) pooled from cadavers have shown cognitive decline reminiscent of early-onset Alzheimer’s disease. Their dementia likely arose from transmission of the bits of amyloid-beta protein that lie behind Alzheimer’s delivered along with the needed hormone, initiating a molecular chain reaction that led to brain effects decades later. Recombinant DNA technology has since provided a pure source of the hormone.

The cognition decline in these people is iatrogenic – caused by a medical procedure. The pooled hGH included infectious proteins, called prions (pronounced “pree-ons”), short for “proteinaceous infectious agent.” The research appears in Nature Medicine from long-time prion researcher John Collinge, director of the University College London Institute of Prion Diseases, and colleagues.

The team followed 8 patients. Two of the five with clinical signs of Alzheimer’s died during the investigation, and autopsy revealed the telltale brain changes. Two other patients had mild cognitive impairment, and the eighth had no symptoms. None had mutations that cause Alzheimer’s disease, ruling out genetics as a cause.

Although the study shows that Alzheimer’s disease is potentially transmissible, the researchers urge that the findings be interpreted with caution and in context.

“We have found that it is possible for amyloid-beta pathology to be transmitted and contribute to the development of Alzheimer’s disease. This transmission occurred following treatment with a now obsolete form of growth hormone, and involved repeated treatments with contaminated material, often over several years. There is no indication that Alzheimer’s disease can be acquired from close contact, or during the provision of routine care,” said first author Gargi Banerjee.

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A primer on prions

A prion disease arises from a protein that can twist, loop, and fold into more than one three-dimensional shape (conformation), even though the underlying amino acid sequences are identical – like pop-beads of 20 colors bent into different shapes. Rarely, one guise of such an acrobatic protein becomes infectious, a prion. It gloms onto others, forcing them to fold in the infectious pattern and propagate it. Prions also clog the tiny cell components that serve as trash receptacles (proteosomes), spreading devastation and enabling cellular debris to accumulate, like New York City during a trash collection strike. In this manner, the nefarious prions “seed” organs, turning an organ like the brain into something resembling a Swiss cheese.

Prions can pass to individuals beyond the ones in which they originate under special circumstances – such as injecting hGH extracted and pooled from cadavers.

Transmission of Alzheimer’s is a first, albeit under extraordinary circumstances. Protein misfolding and spread in several other conditions suggest a prion-like mechanism at work. These include alpha synuclein deposits in some cases of Parkinson’s disease, forms of ALS and Huntington’s disease, Creutzfeldt–Jakob disease (CJD), and Gerstmann–Straussler syndrome. These conditions also have inherited forms.

More than 85 animal species develop prion diseases. The first to be described was in sheep that rubbed themselves raw against fences to relieve itch – their condition was named “scrapie.” Their brains became riddled with holes. Scrapie spread as the animals were fed mashed brain matter from their fellow ovines.

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A stylized slice through an Alzheimer’s brain depicts amyloid-beta plaques in brown and tau tangles in blue.

From cannibalism to mad cows to CJD

The first prion disease of humans, kuru, was discovered among people living in the remote mountains of Papua New Guinea in the 1950s. The story is one of my favorites in all of biology; I’ve told it in several books.

“Kuru” means “to shake.” The disease began with wobbly legs, then trembling and whole-body shaking. Uncontrollable laughter led to the name “laughing disease.” Speech slurred, thinking slowed, and walking and eating became impossible. Death came within a year.

The disease was traced to a ritual in which the people ate their war heroes to honor them. When women and children prepared the brains for consumption, prions entered cuts and abrasions and they became infected. At first, the disease was thought to be inherited because it affected relatives. But the women and their children fell ill from a shared environmental exposure, not a mutation.

The new report in Nature Medicine fleetingly mentions kuru and the cannibalism route to prion disease. “Since the cessation of this practice in the late 1950s, kuru gradually disappeared but enabled documentation of the range of incubation periods of human prion infection; the mean incubation period is approximately 12 years but can exceed 50 years,” the researchers write.

Back in the 1950s, not many people knew about the plight of the remote Fore people. Then in the mid-1990s, a similar prion disease dominated headlines in the UK when more than 120 people ate infectious prions in beef, and died. Popularly called “mad cow disease” after the effects on the unfortunate bovines, the condition was found to be a variant of a rare and horrific brain condition, Creutzfeldt-Jakob disease (vCJD).

Less well recognized was vCJD among people who’d received hGH pooled from the pituitary glands of cadavers, between 1959 and 1985, when recombinant hGH took over treatment. The dose was massive – typically 50 or more cadavers per year of treatment per patient, most of them children or teens with time for the infectious prions to spread. At least 1,848 patients with short stature developed vCJD, mostly in the UK. A history of human growth hormone therapy is here.

Autopsies of some of the patients revealed the classic amyloid-beta pathology of Alzheimer’s disease, but the CJD would likely have killed these patients long before the cognitive symptoms of Alzheimer’s had had time to manifest. But when researchers injected mice with saved samples of the tainted hGH, the rodents, which develop much faster, indeed showed the classic amyloid-beta plaques of Alzheimer’s.

Experts urge not to worry

When recombinant DNA technology was invented in the 1970s, it instantly provided a way to mass-produce a medicinally important protein without the taint of passage through an organism – like the gunky brain of an itchy sheep or a staggering, sick cannibal. Recombinant human growth hormone (rhGH) became available in 1985. And so the researchers urge that their report consider the history and not be taken out of context.

“There is no suggestion whatsoever that Alzheimer’s disease can be transmitted between individuals during activities of daily life or routine medical care. The patients we have described were given a specific and long-discontinued medical treatment, which involved injecting patients with material now known to have been contaminated with disease-related proteins,” explained Collinge. The possibility of transmitting amyloid-beta pathology should lead to ensuring that measures to prevent accidental transmission via other medical or surgical procedures are in place, he added.

Co-author Jonathan Schott stressed that although the circumstances that inspired the study are highly unusual, the findings “provide potentially valuable insights into disease mechanisms, and pave the way for further research, which we hope will further our understanding of the causes of more typical, late-onset Alzheimer’s disease.”

Ricki Lewis has a PhD in genetics and is the author of the textbook Human Genetics: Concepts and Applications, soon to be published in its fourteenth edition. Follow her at her website www.rickilewis.com or X @rickilewis

A version of this article was originally published at PLOS Blogs and has been republished here with permission. PLOS can be found on X @PLOS

A nutritionist reflects on the sad state of health education about GMOs and farming at schools and universities

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A nutritionist reflects on the sad state of health education about GMOs and farming at schools and universities

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Ruth MacDonald, PhD, Author, Professor and Chair, Department of Food Science and Human Nutrition, Iowa State University, and Interim Senior Associate Dean for the College of Agriculture and Life Sciences | February 2, 2024

Highlights:
  • Anti-GMO propaganda documentary films have become a prime source of misinformation
  • Most teachers have no background in farming or health issues and readily pass along anti-biotechnology jeremiads as facts
  • Scientists are frustrated trying to counter this tsunami of fear-mongering when the education establishment is uniformly in the thrall of anti-GMO propaganda

In 2018, Iowa State University hosted about 300 high school students from around the state who participated in the World Food Prize Youth Institute. These students spent the last year working on a research paper that investigated a major food or health topic in a developing country. They came to our campus to present their papers, and engage in discussions with faculty, representatives from non-profit organizations, industry and government leaders. I served as one of the discussion leaders and had the opportunity to talk with several students during the day.

The issues that the students addressed in their papers centered on the struggle many developing countries face with malnutrition, subsistence farming and insufficient agriculture production. During the day, the issue of genetically modified crops arose repeatedly. Because these students are from Iowa, a major farm state, they tend to be aware of the use of GMO crops, although only a small portion of them come from farm families.

Some of them suggested that developing countries should adopt Western farming practices, including GMO technologies, so that they could feed their people. Most were aware of the controversies about GMO use in developing countries but were also confused about the scope of the issue.

In our conversations, I came to realize that their education about GMO foods in their classrooms was heavily based on documentary films; one might say propaganda films, since almost all of them are heavily biased and against agricultural biotechnology.

In our conversations, I came to realize that their education about GMO foods in their classrooms was heavily based on documentary films; one might say propaganda films, since almost all of them are heavily biased and against agricultural biotechnology.

One student, from Prairie City High School, shared with me that his teacher showed ‘GMO OMG’ to his class as an introduction to the technology. This documentary by Jeremy Seifert fully opposes the use of GMO technology and according to most independent critics is laden with inaccuracies and misinformation. Esteemed film critic Roger Ebert called it a “misfire,’ grudgingly giving it a 1-star rating, writing: “Seifert’s arguments are dependent on unconvincing testimony and leaps in logic. …GMO OMG is do-gooder propaganda. … [It] is a jeremiad, not a lesson for the masses.”

I asked the student if his teacher made any effort to provide a balance to the documentary, if there were other readings or discussions. His answer was a disappointing ‘no’ and in fact the teacher seemed to think the content was reliable. The student that shared this story told me that he had a family member that worked in the seed industry, and he had done some additional reading on his own, so he knew that the ‘GMO OMG’ documentary was not accurate, but many of his peers were convinced of the dangers of GMO foods after watching the movie.

If you are a teacher, and you want to engage your students in a discussion about GMOs, where could you go for information? There is no core curriculum about this topic. In fact teachers are not even required to teach about food or nutrition. Without a reliable resource, you might turn to the internet and look for a documentary.

There are many options to choose from, I found 10 with one click on Google. Like ‘GMO OMG’, these 10 documentaries all paint a negative and unscientific perspective of GMO technology. Because there are so many junk films and they are so readily available it makes sense that teachers often rely unthinkingly on sensationalized documentaries about GMOs that provide a one-sided perspective. Compound this with the fact that teachers, even those that teach health, rarely take a course in nutrition, food science or agriculture and may not be able to distinguish accurate information about this topic.

Recently, I was invited by an elementary school teacher in another state to speak to one of his students who wanted to do a research project about GMO foods. I volunteered to do this and agreed to speak with the student on the phone several times over the course of a month. I provided scientifically-based information about how GMOs are developed, what they are used for, how they are tested for safety and several references that described scientific evidence for their safety.

If you are a teacher, and you want to engage your students in a discussion about GMOs, where could you go for information? There is no core curriculum about this topic.

When the student had completed her project, the teacher shared a video link with me of the presentation. Much to my surprise the presentation focused only on how GMOs were unsafe for people, animals and the environment, with the student proudly concluding that GMOs should be banned.

The teacher was clearly very pleased with this presentation and made no effort to question the sources used by the student for accuracy or peer evaluation. The science-based information I provided was completely left out of the presentation. In 2014 I agreed to work with Red Line Editorial to serve as a ‘qualified consult’ on a book preliminarily called ‘Genetically Modified Foods for Children’ in a series called Food Matters. The editor wrote to me:

The book is aimed at a 3rd-6th grade audience. We would like feedback on the manuscript to address whether the topic is being covered evenly and fairly and to know if we are misrepresenting any information.

With the hope that I could provide scientific accuracy to this topic for children, I agreed to review the text. The first draft of the book was sent to me and I made significant edits. In my response to this draft I wrote to the editor,

The major concern I had with the original text was the undercurrent that GMO technology is actually bad and should be avoided. This is reinforced by the sidebars and activities which I do not support and have recommended be deleted. There is strong scientific evidence that GMO foods are safe for humans and animals and there are no credible sources that contradict that evidence. This is the perspective that I tried to convey in my edits. I would be happy to dialog with the author about these edits or provide additional references as needed. I ask that I be allowed to see the final version and would only allow my name to be associated with a text that I believe accurately reflects the main-stream scientific evidence.

Several weeks later I received the final version of the text that clearly made none of the changes I had recommended. In fact, the title of the book was changed to “Genetically Modified Food” with a picture of protestors holding up a sign that read “GMOs Must Go.”

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At that point I withdrew my engagement with the editor, writing:

That is unfortunate that you are choosing to promote a non-scientific perspective on this topic. The images you are using instill fear and warning to young children that are not warranted based on the preponderance of scientific and medical evidence. I had hoped that the authors wanted to inform and educate. That does not seem to be their goal and I do not want to be part of that approach. We should be encouraging scientific thinking and evidence in our youth, not promoting non-science emotional perspectives.

I suspect that the author, Rebecca Rissman, received great support for her perspectives from the other content reviewers that were asked to review this book, and my comments were considered the minority vote. So despite my efforts to correct misinformation, this book is available for elementary school teachers as a resource to instruct students about GMO technology.

During lunch at the Youth Institute, I sat with a group of students from three different schools and asked them what they had learned about GMOs in class. Some had never discussed the topic and others mentioned documentaries they watched. When I asked if anyone had seen ‘Food Evolution,’ the Neil deGrasse Tyson-narrated film that is widely considered the one scientifically-grounded documentary on this subject, there were blank stares.

This documentary was funded by the Institute of Food Technologists and does an excellent job of portraying the scientific evidence for GMO safety. The website indicates the video will be available for classroom use during 2018. But as those of who have been in the GMO debate for the past 15 years know, providing scientific evidence for safety or environmental impacts of this technology does not easily change minds. The preponderance of media available today about GMO technology are sensationalist and fear-mongering, so why are we surprised that that is the message our students are getting?

Many of my colleagues have shared similar experiences of being unable to convince a teacher or a school principal to use scientific evidence rather than popular media to teach students about food and nutrition. Scientists must continue to stand up and raise our voices, especially for our youth. The good news is that scientists are hearing that message and making efforts to communicate what they do and why to the public.

I personally, will not decline any request to speak to a group or work with a teacher or student to help them understand GMO safety, despite my lack of impact so far, because I truly believe in the science. If we all do that perhaps we together we can change the direction of this dialogue.

Ruth MacDonald x

Dr. Ruth MacDonald is Professor and Chair, Department of Food Science and Human Nutrition, Iowa State University, and Interim Senior Associate Dean for the College of Agriculture and Life Sciences. She holds a PhD in Nutrition, minor in Food Science, and Masters in Nutrition, minor in Physiology from the University of Minnesota, and is a Registered Dietitian. Her research interests include the role of dietary factors in cancer progression, specifically breast, colon and prostate cancer. With funding from the USDA she leads the Cyclone Scholars program that provides tuition scholarships to underrepresented students majoring in food science and human nutrition. She is co-author of Understanding Food Systems: Agriculture, Food Science and Nutrition in the United States (Elsevier, 2017). Follow her on X: @isumacd

Global Farmer Network (GFN) is a non-profit advocacy group led by farmers from around the world who support free trade and farmers’ freedom to choose the tools, technologies and strategies they need to maximize productivity and profitability in a sustainable manner. Established in 2000, the Global Farmer Network is committed to inserting the worlds farmers voice in the global dialogue regarding food and nutritional security. The Global Farmer Network identifies, engages and supports strong farmer leaders from around the world who can work with others to innovate, encourage and lead as full stakeholders in the work that is being done to fill the world’s food and nutrition security gap in a sustainable manner.

The Genetic Literacy Project is a 501(c)(3) non profit dedicated to helping the public, journalists, policy makers and scientists better communicate the advances and the technological, ethical and religious challenges ushered in by the biotechnology and genetics revolution, including CRISPR gene editing, in biomedicine and agriculture.

GMO Beyond the Science III

Read the full series

Viewpoint: Why proposals to ban all 12,000 PFAS chemicals contradict science

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I have previously authored many articles about per- and polyfluroalkyl substances (PFAS), also known as “forever chemicals,” and the misinformation and lack of scientific credibility surrounding them. However, Europe has outdone the U.S. on the absurdity of their proposed regulations on these chemicals. On February 7, 2023, the European Chemicals Agency (ECHA) proposed to ban all PFAS, which would affect more than 12,000 chemicals. To do this, they used a definition of PFAS so broad that it includes almost any chemical that contains fluorine [1]. What is going on?

I became aware of the ECHA proposal after reading an excellent article, The EU’s Per- and Polyfluoroalkyl Substances (PFAS) Ban: A Case of Policy over Science, published in the journal Toxics written by Tommaso A. Dragani.

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Mr. Dragani is currently the Chief Scientific Officer of Aspidia, a company involved in “bioremediation of pollutants and the production and delivery of natural and synthetic enzymes and other proteins.” Before assuming this role, he was the Research Laboratory Director of “Genetic Epidemiology and Pharmacogenomics” at Italy’s National Cancer Institute, publishing over 189 scientific papers in peer-reviewed journals, mainly in toxicology and genetic epidemiology.

Mr. Dragani was extremely gracious and agreed to an interview where I asked him questions about the ECHA proposal and topics in his article. Our discussion has been lightly edited.

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SG: You clearly believe that the European Chemicals Agency was in error in proposing to ban an entire class of chemicals, the PFAS. Could you please explain why?

TD: I believe that ECHA is wrong to propose to ban an entire class of chemicals because PFAS are not a small number of similar compounds, but the term covers about 12,000 compounds with very different physical, chemical, environmental, and biological properties. There is no evidence of health risks for most PFAS, but banning them has strong negative consequences. For this reason, I do not recommend a blanket ban.

SG: What are some unintended consequences if the proposed ban becomes law?

TD: In my opinion, there are two distinct and unintended negative consequences to consider:

First and foremost, the proposed ban, if implemented, will result in the discontinuation of the production of fluoropolymers in Europe. These materials, which pose no known health or environmental risks, play a vital role in several industries. They are used in medical devices, computers, cell phones, and in the development of high-performance materials for aerospace, automotive, photovoltaic cells, electric motors, and more.

Second, the search for potential alternatives to PFAS could lead to the introduction of less effective and potentially more hazardous substitutes. In the absence of thorough toxicity assessments, these alternatives could be rushed to market, raising concerns about their safety.

SG: What are fluoropolymers, and why should they be considered a separate group from other PFAS?

TD: Fluoropolymers represent a distinct category within the PFAS group due to their significantly larger molecular sizes, often exceeding 100,000 dalton (Da), and more complex molecular structures. These substantial molecular sizes provide a critical advantage: they limit the uptake of fluoropolymers by living organisms, thereby reducing the likelihood of bioaccumulation. In addition, the bulkiness of fluoropolymers results in lower solubility in water, further limiting their ability to disperse in the environment. As a result, fluoropolymers can be classified as low-risk polymers because they meet all the criteria for such classification.

SG: Your article makes clear that PFAS includes a wide range of heterogeneous chemicals. Is there a way that makes sense to divide these chemicals into smaller groups?

TD: Fluoropolymers are a different chemical category than the PFAS compounds like PFOS and PFOA that have contaminated our drinking water. Given this fundamental difference, I don’t think it makes sense from a public health perspective to lump PFAS into smaller groups based on similar chemical and physical properties. Instead, it’s critical to evaluate each specific substance independently to determine whether it raises toxicity concerns.

SG: How do the structures of these chemicals affect their toxicity? Why should we expect that different PFAS affect the human body differently?

TD: The toxicity of PFAS is indeed influenced by their chemical structures, as these structures dictate how PFAS compounds can interact with specific receptors or proteins in our bodies. While our understanding is still evolving, we can highlight some general characteristics that shed light on this issue:

  • Carbon chain length: The length of PFAS carbon chains plays a role in toxicity. PFAS with longer chains tend to be less toxic because they are less likely to be absorbed by the body.
  • Functional groups: The presence of functional groups, such as sulfonate or carboxylate, can affect the water solubility of a PFAS compound and thus, its potential for toxicity.
  • Isomers: Some PFAS compounds exist as isomers, which means they have the same chemical formula but different structural arrangements. These structural differences can lead to different toxicity profiles because isomers interact differently with biological receptors.

However, it is important to recognize that our understanding of PFAS toxicity is still limited, and making accurate predictions can be challenging.

SG: What are Toxicity-Equivalent Factors (TEFs), and why shouldn’t they be used to evaluate the toxicity of PFAS?

TD: In my article, I discussed the concept of toxic equivalent factors (TEFs), which serve as a tool for regulators to assess the collective toxicity resulting from exposure to chemical mixtures. However, for TEFs to be scientifically valid, they should be applied to chemically related substances that act through the same mechanism of action and produce similar types of toxicity.

Unfortunately, this principle does not apply to PFAS because they are an extremely diverse group of chemicals. PFAS show significant variation in how they interact with our bodies (toxicokinetics) and may not share a common mechanism of action. In addition, mechanisms observed in laboratory rodents, which are typically used to derive TEFs, may not be directly applicable to humans.

In summary, PFAS present a unique challenge due to their heterogeneity, diverse toxicokinetics, and potential variations in their mechanisms of action. This complexity makes the use of TEFs in the toxicity assessment of PFAS mixtures inappropriate.

SG: What role can bioremediation play in removing PFAS?

TD: Bioremediation is a remarkable process that harnesses the metabolic power of microorganisms and their enzymes to break down contaminants. It’s cost-effective and environmentally friendly – it doesn’t rely on harmful chemicals or incineration.

I believe bioremediation is a promising but largely untapped opportunity that could significantly improve the management of PFAS contamination soon. This belief led me to found ASPIDIA, a startup company dedicated to conducting research projects focused on the bioremediation of PFAS.

Unfortunately, securing funding for such endeavors can be quite challenging in Italy. I am very grateful for your efforts to raise awareness of this issue. I hope that in the not-too-distant future, we will be able to raise the necessary funds to conduct important scientific research in bioremediation – a field with the potential for immense benefits to both our health and the environment. Your support is invaluable in making this vision a reality.

SG: If you were the regulator, what would your approach be to regulating PFAS?

TD: As a regulator, my approach would be targeted and strategic, focusing primarily on managing PFAS compounds known to pose high risks – of which there are few, less than a dozen. For the remaining PFAS, an individual assessment of their toxicological properties would be essential, looking at each substance on a case-by-case basis. Notably, manufacturers are already undertaking aspects of this assessment, and further implementation would not result in significant cost increases.

At the same time, I would like to emphasize the importance of industrial processes that minimize emissions of potentially toxic substances into the environment. I would like to encourage research and development efforts, particularly in the promising area of bioremediation.

This multi-faceted approach would ultimately lead to more effective protection of both human health and the environment, thereby significantly reducing potential adverse impacts on the well-being and quality of life of citizens.

Notes:

[1] “PFASs consist of a fully (per) or partly (poly) fluorinated carbon chain connected to different functional groups.” European Chemical Agency

Susan Goldhaber, M.P.H., is an environmental toxicologist with over 40 years’ experience working at   Federal and State agencies and in the private sector, emphasizing issues concerning chemicals in drinking water, air, and hazardous waste.  Her current focus is on translating scientific data into usable information for the public. 

A version of this article was originally posted at the American Council on Science and Health and is reposted here with permission. Any reposting should credit both the GLP and original article. The ACSH can be found on X @ACSHorg

Part II — Viewpoint: A case study of how organic advocates massage data from meta-studies to promote their ideological agenda

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What is the magnitude of the data fraud polluting scientific research and what are the sources of it?

In part I of this series, we presented evidence that a not insignificant amount of published science and the “knowledge” resulting from it are wrong. There are many reasons for this, including experimental carelessness, differences in how researchers approach statistical analyses, journals’ bias against publishing negative results, and outright dishonesty by investigators. 

Part II describes activist scientists can use meta-analyses to manipulate data to reach a predetermined conclusion.

This is the second part of a two-part series. Read part one here.

When dozens, hundreds or thousands of studies address a science question or controversy, there will invariably be differing conclusions, if no other reason than chance or the use of conflicting data. So, how are research controversies adjudicated and resolved?  An approach favored by the science establishment is to conduct what’s called a meta-analysis. That’s a statistical analysis that combines the results of multiple scientific studies, often randomized control trials. It’s believed by many researchers that systematically combining qualitative and quantitative data from multiple studies, sometimes numbering in the hundreds, is statistically stronger than any single study, turning noise into signal.

Resolving the debate over the nutritional superiority of organic foods

Often times the process works. For years, according to accepted wisdom, organic food was believed to be healthier than conventional alternatives. Many individual studies seemed to suggest that food grown organically is more nutritious, carries fewer health risks, and can reduce the risk of pesticide exposure. But many health professionals had their doubts.

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The issue intrigued two prominent researchers at Stanford University’s Center for Health Policy, Dena Bravata and Crystal Smith-Spanger. Bravata, the chief medical officer at the health-care transparency company Castlight Health, launched the project, she said, because so many of her patients asked her whether organic foods were worth the higher prices, often double or more the cost of conventional alternatives.  

Bravata discovered that she couldn’t look to studies to resolve the controversy. There were literally thousands of them, each with its own data set and often reaching contradictory conclusions. Which ones were most trustworthy?

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“This was a ripe area in which to do a systematic review,” said first author Smith-Spangler, who partnered with Bravata and other Stanford colleagues to conduct a meta-analysis. 

According to the lead authors, they sifted through thousands of papers to identify 237 of what they believed were most relevant to analyze. Their conclusion shocked and rocked the food industry. 

“Some believe that organic food is always healthier and more nutritious,” said co-author Smith-Spangler. “We were a little surprised that we didn’t find that.” Most notably, although they found that organic food contained less added pesticides, they also found that the levels of all foods fell within the allowable safety limits. 

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The Stanford study’s conclusion touched off a tempest, with angry pushback from acolytes and self-interested elements of the organic industry, such as food writers Michael Pollan and Mark Bittman. 

But numerous independent (not funded by the organic or conventional food industries) subsequent meta-analyses have not challenged the Stanford study’s conclusions.  The most convincing: a follow-up report in 2020 based on 35 studies distilled from 4,329 potential articles by researchers at Australia’s Southern Cross University concluded that the “current evidence base does not allow a definitive statement on the health benefits of organic dietary intake. 

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What can go wrong?

Often, though, meta-analyses can create the kind of misinformation that they were designed to combat.

How are meta-analyses executed? A computer search finds published articles that address a particular question — say, whether taking large amounts of vitamin C prevents colds. From those studies considered to be methodologically sound, the data are consolidated and carried over to the meta-analysis. (Usually the person(s) performing the meta-analysis does not have access to the raw data used in the individual studies, so summary statistics from each individual study are carried over to the meta-analysis.) If the weight of evidence, based on a very stylized analysis, favors the claim, it is determined to be real and often canonized.

The problem is that there may not be safety in numbers because many individual papers included in the analysis could very well be exaggerated or wrong, the result of publication bias and p-hacking (the inappropriate manipulation of data analysis to enable a favored result to be presented as statistically significant). 

Potential p-hacking can be detected by creating a “p-value plot” — how likely it is that any observed difference between groups is due to chance. The first figure below, for example, plots a meta-analysis in which there were 19 papers; in the second figure, the meta-analysis included 14 papers.

Recall that a small p-value is taken to mean that an effect is real, as opposed to having occurred by chance. The smaller the p-value, the more likely the effect is real. If the resulting p-value plot looks like a hockey stick, with small p-values on the blade and larger p-values on the handle (as in the two figures below), there is a case to be made for p-hacking.

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The figures above are derived from meta-analyses of the supposedly beneficial effects of omega-3 fatty acids (left figure) and the alleged direct relationship between sulfur dioxide in the air and mortality (right). They were presented in a major medical journal and purportedly showed a positive effect. But that conclusion is, at best, dubious. 

The p-values are represented along the vertical in each graph. There are, indeed, several small p-values reported below 0.05; taken alone, they would indicate a real effect. But there are more p-values greater than 0.05, which indicate that the claimed effect was a mirage.

Clearly, both cannot be correct inasmuch as there are more negative studies. P-hacking is a logical explanation for the presence of a small number of low p-values. The most likely conclusion is that these meta-analyses yielded false-positive results and that there is no effect. 

Challenge to the science research community

A news article in the journal Nature recently addressed the data on research fraud. The breadth of the misconduct identified by the author, the features editor at the magazine, is shocking, both in terms of its magnitude and how successfully fraud has been institutionalized and commercialized:

The scientific literature is polluted with fake manuscripts churned out by paper mills — businesses that sell bogus work and authorships to researchers who need journal publications for their CVs. But just how large is this paper-mill problem?

An unpublished analysis shared with Nature suggests that over the past two decades, more than 400,000 research articles have been published that show strong textual similarities to known studies produced by paper mills. Around 70,000 of these were published last year alone (see ‘The paper-mill problem’). The analysis estimates that 1.5–2% of all scientific papers published in 2022 closely resemble paper-mill works. Among biology and medicine papers, the rate rises to 3%.

Thus, substantial percentage of published science and the canonized claims resulting from it are likely wrong, sending researchers chasing false leads. Without research integrity, we don’t know what we know. It is incumbent on the scientific community — journal editors, universities, and funders — to find solutions.  

Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health.  He was the founding director of the FDA’s Office of Biotechnology. Find Henry on X @HenryIMiller

Dr. S. Stanley Young is a statistician who has worked at pharmaceutical companies and the National Institute of Statistical Sciences on questions of applied statistics. He is an adjunct professor at several universities and a member of the EPA’s Science Advisory Board.

Biological exceptionalism: How two Italian sisters lived to 100

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In my endless email about COVID-19 popped up a new paper analyzing the health of two Italian sisters who lived to remarkably old ages.

“The Phenotypic Characterization of the Cammalleri Sisters, an Example of Exceptional Longevity,” from Calogero Caruso M.D. of the University of Palermo, Italy, and colleagues, is published in Rejuvenation Research.

Filippa was a “semi-supercentenarian” of 106 years, born December 12, 1911 and who died July 6, 2018. Her sister Diega, born October 23, 1905 and who died June 15, 2019, was a supercentenarian, living until age 113. Among centenarians – those who see their 100th birthdays – only 1 in 1,000 makes it to 110. Only 27 supercentenarians are known in the world.

An article in The New Yorker, “Was Jeanne Calment the Oldest Person Who Ever Lived—or a Fraud?” told the story of the famed French woman, who died in 1997, supposedly at the age of 122. But when historical inconsistencies started popping up, investigators discovered that the woman who died may have been a masquerading daughter. Lauren Collins wrote, “Jeanne Calment … was an accidental icon, her celebrity the result of a form of passivity. For a hundred and twenty-two years, five months, and fourteen days, Calment managed not to die.”

But Filippa and Diega Cammalleri were real – and studied.

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The anti-aging industry is one-size-fits-all

The researchers gave the sisters a detailed questionnaire in July 2017, took all sorts of measurements, and did blood and limited genetic analysis. What their findings reveal about their physiology runs counter to what the “anti-aging” industry promotes to supposedly make us live longer – in several ways.

It turns out that the super-old sisters likely lived as long as they did because of high levels of pro-oxidants and low levels of anti-oxidants, plus steady low-level inflammation. Filippa had an unhealthy cholesterol profile, and the sisters apparently shared a sweet tooth.

“Aging” in biological terms, means “change over time.” Therefore, the only anti-aging strategy is to cease being alive, or to take a ride in a time machine. However, as is clear during this time of the pandemic, popular ideas don’t always make scientific sense.

Consider Sephora, the chain of product-packed cosmetics and skin care superstores. Their anti-aging elixirs include peels, serums, polypeptide moisturizers, oils, the utterly useless collagen (too large a molecule to get under skin) pitera essence (a “miracle ingredient” from sake; as soon as I googled it Facebook tried to sell it to me), lactic acid, retinol cream, leechee nuts, hyaluronic acid, and of course the ever-present anti-oxidants.

Questions and measurements

The sisters lived all their lives in Canicattì, Sicily. What made them tick for so long?

They answered wide-ranging questions. What had made each sister sick? Which drugs had they taken? Did they smoke? Tests assessed depression, cognitive status, activities of daily living, ability to perform complex tasks, and sleeping and eating habits. I didn’t see a mention of exercise.

Metrics included body mass index and bioelectrical impedance analysis. “BIA” measure fat versus lean muscle mass through a weak electric current passed through the back of a hand and a foot.

The family history was straightforward, revealing longevity and colon cancer.

Filippa and Diega’s father Calogero Cammalleri died at 97 of unknown causes, and their mother Maria Di Pasquale died at age of 73 of the cancer. Twin sons died of colon cancer and a third son in an accident.

Diega taught at a primary school; Filippa went as far as fifth grade. The sisters never married and lived together in an apartment. They were wealthy enough to afford a live-in caregiver.

The sisters never smoked, slept 5 to 6 hours a night, and took anti-hypertensive drugs, diuretics, and antiplatelet agents. Diega had macular degeneration and Filippa had cataracts. Both suffered from arthrosis (a breakdown of joint cartilage without inflammation) and osteoporosis.

Filippa was hospitalized at age 100 for a broken femur and five years later for constipation. She had mild dementia. So their medical histories were unremarkable.

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Only for their final decade had the sisters needed help with dressing, hygiene, going to the bathroom, getting around, and eating. During those final 10 years they also couldn’t prepare meals, take care of their finances, do the housekeeping, use the phone, and manage their medications.

As for eating habits, the Cammalleri sisters didn’t stick to the much-praised Mediterranean diet. They enjoyed pasta, extra virgin olive oil, milk, and fruits, but only ate vegetables two or three times a week. The sisters consumed pastries and/or biscuits twice a day, eggs and potatoes once. They ate red or cured meat once or twice a month, but liked white meat chicken and bluefish. The investigators deemed their diet of mostly legumes “monotonous.”

Delving into the data

The sisters were small and thin, technically sufficiently so for the word “cachexia” to appear: “wasting syndrome.” Each woman was a little over 5 feet tall, Filippa weighing 110 pounds and Diega 117. One of the physiological tests (for PhA, aka polyhydroxyalkanoate) attributes their small bodies to fluids leaking out of their cells.

I analyzed the four tables of test results to see if my interpretation matched the researchers’ conclusions. And it did.

The tables list:

  • Anthropometric and body composition values
  • Blood tests
  • Oxidative and inflammatory tests
  • Limited genetic tests (a few genes and microRNAs)

The tables are a nice visual way to present the findings. Each has four columns. Leftmost is the test, then a column for each sister, then a column for normal range for the metric in healthy Italian women aged 50 to 65. Boldface indicates where each sister is out of range, so thankfully I didn’t need to deal with any actual math.

Only a few boldface measurements appeared for all entries except for “oxidative and inflammatory tests.” Of those dozen markers, the twins were literally off the charts.

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My grandfather Sam lived to be 103. He ate his favorite meal, deep-fried crabs, every day.

Paradoxical anti-oxidant patterns and microRNAs spell inflammation

The sisters had low levels of anti-oxidants, such as PON (paraoxonase) and GSH (glutathione), and of the sulfur-containing amino acids needed to make them. Yet they had high levels of MDA (malondialdehyde), a marker for oxidative stress. Elevated KYN (kynurenine) reflected body-wide inflammation, which is part of the innate immune response.

The findings for microRNAs were telling too. MicroRNAs are tiny RNA molecules that flit on and off different combinations of genes, blocking some of them from being transcribed and translated into protein. They’re described as “dimmer switches” for the genome. Combinations of the 2,500 or so microRNAs in the human genome oversee and fine-tune protein production.

The levels of three types of microRNAs circulating in the sisters’ bloodstreams conferred what the researchers call a “longevity phenotype” – a level of inflammation normal for a much younger person.

Was an immune system allowed to simmer on a low burn responsible for a long lifetime without infectious disease?

Limited genetic info

The genetic analysis was just a few markers of aging, not a genome-wide landscape of single-base (SNP) markers, or an exome or genome sequence.

The researchers considered two genes associated with aging: FOXO3A and ApoE.

At one place in Forkhead box O3A (FOXO3A), a person can have two DNA bases of “GG,” two of “TT,” or one of each, “TG.” Having a “G” has been linked to longevity. Filippa was TG and Diega TT. It turns out that the association holds for just some populations, Sicilians not among them.

The ε2, ε3, and ε4 variants of the ApoE gene were also on the menu. This gene is widely known for its association with Alzheimer’s disease risk: the ε4 variant raises risk, ε2 lowers it, and the most common ε3 variant is neutral. The sisters had boring ε3 variants. Again, the genetic associations don’t hold for Sicilians.

Returning to metabolism for a moment because it’s under genetic control, the sisters had borderline unhealthy cholesterol profiles. Diega had low HDL and Filippa had low HDL and also high LDL.

telomere caps xTelomeres were measured. These are the chromosome tips that normally whittle down with age. Longer telomeres might be expected in people who live a long time, but the sisters were again normal.

There’s precedent for the finding that low-level inflammation keeps some folks alive for a long time. A 2015 paper, “Inflammation, But Not Telomere Length, Predicts Successful Ageing at Extreme Old Age: A Longitudinal Study of Semi-supercentenarians,” from researchers at the Centre for Supercentenarian Research, Keio University School of Medicine, in Tokyo, found this to be a commonality among most of the 1,554 very old folks they analyzed.

“We conclude that inflammation is an important malleable driver of ageing up to extreme old age in humans,” they wrote.

What does it mean?

The two sisters who surpassed their 100th birthdays in relatively good health had:

  • Elevated LDL cholesterol
  • Modest, persistent inflammation
  • Oxidative stress
  • Twice-a-day consumption of sweets
  • Limited veggies
  • No protective ApoE genes against Alzheimer’s

Diega and Filippa are clearly exceptional. But they do make the case that one-size-fits-all medicine isn’t always the best way to evaluate health. Journal articles applaud precision medicine, but the average health care consumer is unlikely to encounter it.

My primary care provider has never asked me a single thing about my family health history. If she had she’d learn that there’s no cardiovascular disease at all, yet unhealthy cholesterol profiles. She wants me on a statin. Well, no. She keeps prescribing naproxen, even though it makes me sick, because insurance companies and protocols recommend it be given first because ibuprofen irritates the digestive lining. But ibuprofen does that in only one percent of the population, and that’s not me.

Diega and Filippa were lucky – we don’t know whether they actively did anything to prolong their lives. But the subtext to studying biologically exceptional people is that we learn more about how we vary. And health care providers should consider that their patients could be exceptions to medical rules.

Ricki Lewis has a PhD in genetics and is the author of the textbook Human Genetics: Concepts and Applications, soon to be published in its fourteenth edition. Follow her at her website www.rickilewis.com or X @rickilewis

A version of this article was originally published at Plos Blogs and has been republished here with permission. PLOS can be found on X @PLOS

This article first appeared on the GLP June 5, 2023.

Viewpoint: American Academy of Pediatrics fiasco — International Agency for the Research on Cancer is the cancer at the heart of the anti-glyphosate movement

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In today’s world, due to the lopsided impact of the bullshit asymmetry principle, the internet is overflowing with misinformation. However, amidst this deluge of falsehoods, there are organisations that steadfastly promote scientific facts rather than succumbing to the influence of interest groups or fashion. These organisations and the individuals within them are beacons of rationality serve a crucial role and it’s truly disheartening and frustrating when they deviate from scientific principles, potentially undoing years of collective effort. For instance, the recent promotion of pseudoscience by the World Health Organization (WHO) was a significant blow to those who hold such institutions in high regard. Now the American Academy of Pediatrics (AAP) has seemingly outdone the WHO by publishing an article which parrots the same anti-GMO rhetoric spouted by the synthetic “organic movement”. Contrary to legacy media, what the AAP published was not a scholarly review but a cherry-picked opinion piece, by authors and editors intent on misinforming the public and physicians. Moreover, the organisation doubled down, continuing to propagate the false claims through additional media channels, even after physicians and scientists reached out to discuss the inaccuracies their article contained. In this blog post, I plan to counter what I consider to be the most egregious examples of sleight of hand and flat-out lies in the AAP’s publication.

american academy of pediatrics
American Academy of Pediatrics Headquarters

Founded in 1930 by 35 paediatricians to address paediatric healthcare standards, the AAP is the largest professional association of paediatricians in the United States. It provides a variety of services, including advocating for children and paediatrics, research on health systems delivery, public information and education, continuing medical education and analyses and reviews of child health policy issues. The academy is the most recognised and influential organisation in childhood medicine in the States but it is important to acknowledge that not all the views expressed by the AAP are universally held within the broader medical and scientific community. Different health organisations often maintain varying perspectives on contentious issues which stem from diverse interpretations of scientific data, varying risk assessments, or differing priorities when considering public health and safety. For instance, here in the UK the NHS has a very different view on gender affirming care, circumcision and what drugs can and cannot be given to children. Of course, this does not mean that we should disregard the AAP’s valuable contributions. In fact, quite the opposite is true. Which is why many of us, myself included, were taken aback by the significantly flawed and damaging opinion piece, “Use of Genetically Modified Organism (GMO)-Containing Food Products in Children,”

The paper demonstrates poor quality from the outset by incorrectly defining a GMO:

The term GMO refers to foods (or other products) designed through genetic engineering, a process that introduces a desired trait into the product by inserting novel DNA from a separate organism.

– AAP

A GMO is not limited to an organism resulting from the insertion of novel DNA from a separate organism; rather, it includes organisms with one or more genetic changes made using a narrow range of genetic engineering techniques. The definition focuses on the techniques used, rather than the act of modifying itself, excluding methods like atomic gardening, where plants are irradiated until a beneficial trait mutates. According to the AAP definition, a GMO with a single nucleotide modification from a genetic engineering technique would not be classified as a GMO. This error seems intentional, aiming to evoke “frankenfood” fears and instill reader anxiety, rather than being a mere oversight by the authors.

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One particularly concerning aspect of this anti-GMO paper is that it doesn’t actually provide concrete examples of how consuming or coming into contact with GMOs on the market could adversely affect a child’s health. This stance on GM technology is backed up by nearly  300 scientific and technical institutions from every point on the globe, who have issued reports confirming the obvious: there are no material differences between food produced from the 30 or so fruits, vegetables and grains that have been genetically modified. Surprisingly, the AAP paper even acknowledges that there is no evidence suggesting that genetic engineering affects the taste, smell, or appearance of food products, highlighting that consumers typically do not discern differences between GMO and non-GMO foods. Instead of addressing the potential health impacts of GMOs, the article primarily focuses on the pesticides associated with GM crops while perpetuating the misconception that organic farming does not utilise any pesticides. This is deception, plain  and simple!

The National Academy of Sciences reviewed the safety of GMO food crops in the early 2000s. Those early reviews focused almost entirely on the genetic aspects of biotechnology. They concluded that the novel genes introduced into GMO crops pose no unique hazards to human health. However, neither evaluation examined the potential health hazards of the herbicides used in production of GMO foods, nor did they examine the hazards potentially arising from the use of Bt endotoxins in GMO corn.

– AAP

Here, the authors seem to be strongly suggesting to the reader that there is a lack of research into the potential negative impacts of the herbicides associated with GMOs. This is simply not true and is beyond misleading. Additionally, they contradict themselves by stating that the reviews quoted did not evaluate the potential hazards arising from the use of Bt endotoxin-producing GMOs, when in reality their use and allergenicity was discussed. The reviews also note that Bt insecticides are widely used in spray form by both organic and conventional farmers.

Microbial Bt insecticides targeting lepidopteran pests contain Bt proteins of the Cry1 class, and are widely used in spray form by organic and conventional farmers to control the European corn borer.

These endotoxins occur naturally and therefore are permitted for use as pesticides in organic farming. According to the Organic Consumer Association, at least 57% of organic farmers in the US use themAs these insecticides are so widely used they have undergone extensive investigation and are considered to be more selective and safer for humans and non-target organisms than most conventional insecticides, as they target sites found only in specific groups of insects.

Bt-producing transgenic crops have brought a lot of benefits. For example, in Bangladesh, eggplant farmers have used 50% fewer pesticides per year since 2013, when the GM seed was approved. Farmers have also seen a 10% reduction in health problems, 20% higher yields and a 21% increase in income. This innovation was overseen by the government and many corporations gave up their patent rights to make it happen.

Next, the AAP referred to the 2015 International Agency for Research on Cancer’s (IARC) classification of the herbicide glyphosate as a “probable carcinogen”. The IARC, a body within the World Health Organization (WHO), published a monograph stating that there was sufficient evidence in animals that glyphosate was carcinogenic and limited evidence of carcinogenicity in humans.

Through a highly structured review process based on comprehensive assessments of the published toxicologic and epidemiologic literature, IARC determined that glyphosate is “probably carcinogenic to humans.

– AAP

To be blunt, the IARC’s report misrepresented the science in the limited number of papers they referenced, to the point where one of the authors quoted said the following:

They [IARC] got this totally wrong. They said the study showed there was a relationship…. It’s certainly a different conclusion than the one we came to.

– Keith Solomon

Each and every claim in the document which had a citation can be dismissed, as the authors of the report, deliberately or not, misrepresented the science and in doing so, tarnished the reputation of the WHO. For those who are interested, myself and fellow co-host of The League of Nerds, James, made a video where we discuss the IARC report and show how embarrassingly void it is.

The IARC currently seem to be in the business of publishing a cancer assessment which directly contradicts the global scientific consensus, allowing law firms to leverage threats of class action suits against manufacturers of chemicals caught in the crosshairs and squeeze out billion-dollar settlements or jury verdicts. In my opinion the IARC has devolved into the linchpin of a money-making racket. In the 9 years since the IARC’s publication, numerous regulatory agencies, such as Health Canada, have independently reviewed the IARC decision and found that “glyphosate is not genotoxic and is unlikely to pose a human cancer risk” and “dietary (food and drinking water) exposure associated with the use of glyphosate is not expected to pose a risk of concern to human health”. The European Union regulators have made a decision in 2023, re-registering glyphosate for another decade. This decision was based on an extensive 11,000-page evaluation. Surprisingly, the AAP article does not mention any of these findings and instead reinforces and expands upon the IARC’s controversial conclusion.

The presence of glyphosate and other toxic herbicides in food products is the main hazard to children’s health associated with the consumption of GMO-based foods.

– AAP

These toxic and carcinogenic risks substantially overshadow any theoretical risks to children’s health that may be associated with the introduction of novel genes into corn, soybeans, and other food crops.

– AAP

The AAP article appears to focus exclusively on glyphosate and here draws a conclusion that contradicts the IARC report, which serves as the cornerstone of their argument. The IARC’s own summary statement indicates that there is no known link between trace dietary glyphosate exposure and cancer.

The AAP article further compounds its deception by not only selectively choosing research to support its predetermined conclusion, but also by misrepresenting and grossly exaggerating the referenced data.

The researchers discovered a statistically significant association between the presence of glyphosate and its metabolites in maternal urine samples (collected around the 26th week of pregnancy) and incidence of preterm birth

– AAP

The primary objective of the study was to investigate the impact of prenatal exposure to glyphosate by analyzing the presence of the compound and one of its metabolites in the urine of pregnant women in Puerto Rico. The authors wanted to determine whether there a relationship exists between the concentration of these substances and the occurrence of preterm birth. They reported a higher increased odds of preterm birth with higher alleged exposure to glyphosate at the 26-week mark, however it’s important to note that the study had major constraints. The authors to their credit openly acknowledge these limitations, with a significant caveat being that there are multiple sources of the compounds under examination.

The present study is limited in several ways. In addition to being an environmental degradate of GLY, AMPA is a breakdown product for amino polyphosphonate chemicals, which may be used as detergents, antiscaling agents, and fire retardants.

The authors acknowledged that the correlation was only observed at the 26-week mark. They also recognised the ambiguity surrounding this finding, questioning whether it indicated a potential increased susceptibility to glyphosate later in pregnancy, or if it was simply a result of the larger sample size. The paper concluded by emphasising the need for further research to clarify these uncertainties.

We report consistent findings of increased odds of PTB with higher GLY and AMPA exposure biomarkers at Visit 3 but not Visit 1 or the visit average. It is unclear if this shows a potentially increased susceptibility to GLY exposures occurring later in pregnancy or if it was an artifact because Visit 3 had the largest sample size. We compared demographics across the three study groups to look for any notable differences between them. A visual examination of characteristics across groups did not reveal any major differences between them.

The decision of the AAP to reference this research paper raises concerns due to its limitations and could be seen as deceptive, especially given the potential implications for public health. It is clear that its inclusion in the AAP article is to fuel pre-existing concerns regarding glyphosate found in urine published in other questionable studies. However, the presence of glyphosate and its metabolites in urine is not inherently a negative finding. The fact that the human body excretes these compounds and does not accumulate them should be seen as a positive. Furthermore, it is crucial for individuals to realise that the concentrations of these compounds detected in urine are exceedingly small. The saying “the dose makes the poison” is particularly relevant in this context, as it underscores the principle that toxicity is dependent on the dosage received. Therefore, the mere presence of these compounds in trace amounts does not necessarily indicate harm, and it is essential for people to grasp the significance of dosage in determining toxicity.

The glaring shortcoming of this scientific article lies in its exclusive focus on herbicides used in conjunction with GMOs while completely omitting any discussion of herbicides associated with organic farming. Compounds used in organic farming, such as chlorine dioxide, copper sulphate, lime sulphur, potassium hypochlorite, and ferric phosphate, often possess higher toxicity, reduced biodegradability and an increased tendency to bioaccumulate. Additionally, organic farming may require larger quantities of these compounds for effective application, a fact that is conveniently left unmentioned. It’s important to emphasise that I’m not suggesting organic pesticides are inherently harmful when used correctly; rather, I am highlighting the hypocrisy evident in the AAP’s selective focus. As an agency primarily concerned with the health and wellbeing of children and young adults, the AAP’s disregard for addressing the potential risks associated with organic farming practices is deeply troubling.

Organic farming, often championed as a healthier and environmentally friendly alternative, is in reality a marketing strategy that capitalises on and perpetuates the fears and misconceptions of its consumers, to charge a premium for products that are no different than their conventional counterparts. This trend has tangible consequences. While listening to a podcast discussing this paper, I heard a distressing story about a doctor dealing with a child who was failing to thrive because the parents insisted on feeding the child organic food, which they could not afford. Consequently, they ended up feeding their child less, highlighting the real-world impact of these deceptive narratives.

The AAP is perpetuating fear and misinformation among the very people it exists to protect. When influential organisations neglect to provide a comprehensive and balanced view of scientific findings, they inadvertently impede the informed decision making of individuals, thus hindering the advancement of knowledge and the betterment of society.

I hope they see the errors of their way and post a retraction soon.

Myles Power is a chemist from the North East of England, who loves to make videos trying to counter pseudoscience and debunk quackery in all of its various forms. Find Myles on X @powerm1985

A version of this article was originally posted at Myles Power’s blog and is reposted here with permission. Any reposting should credit both the GLP and original article. 

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