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Food Revolution: The History of GMOs and Transgenic Corn

Humans have manipulated their environment since Homo sapien began to roam the Earth over 100,000 years ago. Over time, we have learned to optimize our existence on the planet through altering different natural surroundings – be it discovering fire, domesticating wild animals, and utilizing wood, stones, and metals as building materials to name a few. However, food remains nature’s most valuable commodity for humans, and like other aspects of nature we have been able to harness its power for maximum utility.

While humans have been modifying food crops for thousands of years, in the past 100 years advances in biotechnology have allowed us to manipulate nature’s bounty more than ever before through the rise of genetically modified organisms (GMOs). However, the rise of GMOs has fueled speculation and fear, raising ethical and health concerns for how we may be manipulating the food we all eat in ways we don’t understand.

One such controversial genetically modified crop is corn. Corn’s ability to grow easily and inexpensively along with an abundance of calories has placed it amongst the world’s most versatile and important crops. With the advent of this new technology, corn, amongst other crops, has undergone radical transformations yielding both tremendous benefits and serious risks. This paper will outline the history of human modification of food, the birth of genetic modification of crops through recombinant DNA, the specific biotechnology processes in altering crops, and finally a discussion of the promises and risks of genetically modified corn.

Human’s began actively manipulating nature for food production 10,000 years ago

The History of GMOs

Humans began to transition out of a hunter-gatherer lifestyle into an agricultural based one around 10,000 years ago, and this agricultural lifestyle was the driving force of society up till only around 100-120 years ago. Till the advent of the industrial revolution, humans have spent millennia learning how to enhance the plants and animals around them to maximize their food yield. Those who raise concern over the recent genetic alteration of food ignore how all early domestication of crops was also genetic modification by breeding desirable traits in plants from the random mutations that would occur in each crop generation.

The selective crop breeding to produce yield of a certain size, color, shape etc. has been so drastic that most of our staple crops (including strawberries, wheat, cabbage and corn) aren’t even remotely similar to any of their ancestors in the wild and could in fact no longer survive now without human intervention and care (Parrott 2006).

The industrial revolution of the last century started to shape what today’s system of modern agriculture looks like. As more advanced machinery and technology was introduced into the field, we began to see improved seed distribution, mineral and synthetic fertilizers, and improved farming techniques. However, the industrial revolution was also occurring alongside another revolution – the beginning of molecular biology.

For years scientists had been sure a class of cellular molecules had to be coding all the individual traits they were seeing in organisms. It wasn’t until Oswald’s Avery’s hallmark experiments with Pneumococcus in the 1940s that identified those molecules as DNA (Hauserman 2013). As DNA continued to be characterized throughout the later half of the 20th century, the most important discovery for GMOs was that of recombinant DNA.

Recombinant DNA means the ability to extract genetic material from one organism, artificially introduce it into another organism, and replicate that organism and have it express the foreign genetic material. In 1971, Paul Berg was working at Stanford University during his landmark gene splicing experiment where he was able to slice a piece of Lambda virus DNA using restriction enzyme EcoRI and insert it into Simian Virus 40 which had been cut with the same restriction enzyme.

The two types of DNA were rejoined into a single circular loop and the first recombinant DNA (rDNA) was created (Chemical Heritage Foundation). Scientists Herbert Boyer and Stanley Cohen were able to build on this work by inserting this rDNA into another organism to see if the genetic contents were able to be expressed in a new host.

In 1973, the two created a recombinant DNA plasmid by inserting the genes for resistance to bacterial antibiotic tetracycline into a plasmid. The plasmid was then transformed into a bacterial culture of E.coli and the only colonies that survived when exposed to tetracycline were those that contained the plasmid (Chemical Heritage Foundation). 

These experiments showed that genetic material could indeed be transferred between species. The result of Berger, Boyer and Cohen’s work has been nothing short of a scientific revolution in the last 40 years – we now can select traits we prefer from different organisms from different species and express them in something entirely different. The agriculture industry was one of the primary beneficiaries of this breakthrough.

In 1988, the world’s first genetically modified crop was created. Recombinant genes resistant to the herbicide had successfully been inserted into soybean. The insertion of a single gene which produced an alternate enzyme involved in aromatic amino acid biosynthesis made soybean tolerant to the herbicide glyphosphate (Chassy 2007).

Herbicide tolerant soybeans transformed the market for soybean production, farmers now had a labor efficient, environmentally safe and inexpensive way to control weeds. Genetically engineered soybean was such a success that 93% of the world’s soybeans are now grown this way (Shetterly 2013). The success with soybean launched a cascading snowfall as scientists around the world rushed to patent dozens of genetically modified seeds for different crops through the mid to late 90s.

Over this last decade, genetically modified crops have been planted on more than a billionacres across the world (Chassy 2007). It’s estimated that these new techniques have brought farmers around the world an additional $27 billion in revenue and reduced pesticide use by 224 million kg (Chassy 2007). As the boom set off for GMO’s after the success of soybean, one company emerged as a clear leader in the industry of transgenic crops – Monsanto Company.

By and far the largest producer of GMOs, the Monsanto Company pioneered the core technologies in the field of transgenic crops.

Five Steps to Monsanto’s Secret Sauce

The Monsanto Company was founded back in 1901 as a chemical company in St. Louis, Missouri and produced a variety of different products used through World War I, World War II and the post-War era. Monsanto became a player in the agricultural biotech industry in 1985 when it acquired G.D. Searle & Company and put its foot in the door with agriculture and animal/plant health.

Eleven years later, Monsanto purchased Agracetus to begin producing transgenic cotton, soybean and peanuts and proceeded then to buy out DEKALB, Cargill and Seminis to become the world’s largest seed company it is today (Bravo 2014). Monsanto’s most famous product is Roundup herbicide. This became the most used herbicide in the United States till reports emerged of its potential toxicity and possibility of containing carcinogenic material (Bravo 2014).

While their herbicide remains controversial, their technical expertise in seed modification is tough to rival. Using these five steps, Monsanto has been able to pioneer the development of almost every major genetically modified crop on the planet.

First, find a new trait. You can’t produce a genetically modified organism without identifying the trait you want the plant to have, and then finding what other organism already possess it. This process involves hundreds of thousands of experiments to determine what specific gene is in involved in which process and how it can affect the overall trait you’re hoping to select for.

Second, extract the gene. Monsanto engineers have developed proprietary technology called a “chipper” that uses high powered cameras and object-recognition algorithms able to shave off just a tiny piece of a seed, analyze it with genome mapping technology and isolate the particular gene of interest (Boyle 2011).

Third is trait insertion. Monsanto has developed what’s known as a “gene gun” which is a .22 caliber charge that fires a metal particle coated with DNA into plant tissue and is able to insert foreign DNA into the host crop genome that way. Recently a new technique requires placing the seed under incredible amounts of stress (heat, pH, nutrient starvation) and exposes is to a bug Agrobacterium tumefaciens to insert new proteins into its chromosome (Boyle 2011).

Fourth is the growth chamber. In massive growth chambers, seedlings are tested drought tolerance, salt tolerance, pest and disease resistance, etc.

Finally, the newly prepared seeds are planted. Monsanto provides very specific instructions regarding plant spacing, water and fertilizer use and plant population. Once your seed is planted, your genetically modified organism is ready to grow.

The Corn Revolution

Though Monsanto has had success with many GMO crops, the story for genetically modified corn is more complex. Corn, more formally known as maize, was one of the first crops in history to be domesticated. Humans learned early on how to cross-pollinate a scraggly grass called teosinte which contains minute fruitcases into the juicy corn kernels we grow today (Gewin 2003). In fact, the bright yellow corn husks we think of have never existed in the wild; they are entirely a product of selective breeding over thousands of years.  

The origins of its domestication begin in Mexico 9,000 years ago where it spread through the Americas as a staple crop capable of being able to be produced quickly and inexpensively. These capabilities make corn one of the most widely grown products in world; in fact, the United States is the world’s largest producer and exporter of corn (Shetterly 2013).  Accounting for more than 95% of the US’s total field grain production, the US pumps out corn from over 90 million acres of corn fields, laying mostly in America’s heartland.

Corn remains one of our most productive crops in terms of how many different products are corn derivatives. From the husk to the kernel, there are over 100 different corn byproducts. The most common we see are products like corn starch, corn syrup and corn oil. There are a range of other dietary by products most notably in cereals and baking mixes but also in more obscure products such as ice cream, chewing gum and coffee (GSMC). In fact genetically modified corn is found in 70% of the processed food supply (Gewin 2003).

The U.S. is the world’s largest producer of corn – a crop which is found in more than 70% of the world’s processed food supply

Corn byproducts extend into non-dietary fields as well, turning up in adhesives, paper cups, toothpaste and medicines as well as the use of corn in ethanol production(GSMC). While dry-milling and wet-milling operations use fermentation to extract ethanol from corn, scientists have begun to genetically modify corn itself to produce ethanol. The biotech company Syngenta has produced a genetically engineered corn that contains a synthetic microbial amylase (extracted from microbes near ocean hot-water vents) which is able to break down corn starch into sugar more easily (Pollack 2011).

Given the broad use of corn and corn products, its understandable why producers were eager to experiment with genetic modification to massively scale up its production. One of Monsanto’s first modifications to corn was using Bt technology and the rise of Bt-corn.

Bt stands for Bacillus thuringienis which is a soil bacterium that produces several crystal proteins that destroy the gut of invading crop pests (Gewin 2003). Several of these crystal (cry) proteins were engineered into corn to provide innate herbicidal properties and have been planted widely. It is hard to argue with the benefits that Bt-corn, along with a range of other Bt-crops, has brought to farmers.  

Not only has pesticide use has dropped by 50%, but certain industries like Alabama’s cotton fields and Hawaii’s papaya groves have been single handedly saved by Bt-crops against cotton bollworm infestations and the papaya ringspot virus. Moreover, the International Council for Science (ISCSU) has found that Bt-crops have lower levels of carcinogenic mycotoxins produced by fungi because there are fewer insect holes in plant tissue now.

While corn seems like a relative success, several risks remain. The concern today is that this broad-scale planting of Bt-corn will render the toxin ineffective over time as pests will grow resistant to the secreted toxin.

The Environmental Protection Agency is so afraid of Bt resistant pests that they’ve required 20% of Bt-corn fields also be planted with non Bt-corn so to slow the rate of pest resistance. More alarmingly is the risk of gene flow to other species. When pollen and seeds move in the environment through air/animals, it can transmit these new genetic traits to close by crops or other relatives through horizontal gene transfer.

The fear is that if these new seeds spread into the wild, they will have a competitive advantage over the local organisms and will displace valuable genetic diversity (Gewin 2003). Instances of this have already occurred in western Europe, where genetically modified sunflowers completely took over the ecosystem near a farm and in Mexico where modified corn replaced all the local plants near a farm. Because of their ability to out compete the local flora and fauna in terms of nutrient utilization and insect protection, Mexico has tentatively banned transgenic corn being planted in its fields (Gewin 2003).

Despite the risks, it seems unlikely that the GMO boom will bust any time soon. The value added from genetically modifying our staple food crops have simply paid too large of dividends to curtail all planting and development of potentially problematic crops. While the risks posed by GMO’s are seemingly real, there is simply not enough long-term data to conclude they are riskier (Gewin 2003).

Humans are not unfamiliar with taking these kinds of risks with their food however. For millennia we have been selectively breeding and manipulating our staple food crops to produce the yield we desire. This is simply another chapter in our ongoing quest to conform nature’s products. The discovery of recombinant DNA methods along with the advent of new technology which is allowing companies like Monsanto to be able to identify novel traits, isolate them, insert them into crops and plant them around the world is allowing for one of the greatest agricultural booms in human history.

Never before have we produced as much food as we are now (Chassy 2007) despite growing populations, shrinking arable land and depleted resources, and all of this can be attributed to the brilliant scientists who’ve been able to maximize the power of a single seed.

Given that there is currently harsh reaction to some governments already to GMO’s, its inevitable that the wheels of innovation will continue to turn to enhance modified seeds more than they already are to solve these problems. As with any new revolutionary technology, government regulation should continue to stay in place to ensure the long-term sustainability of GMO’s. In the end they may have no choice, genetically modified organisms are here to stay.


Works Cited

1- Boyle , Rebeca. 2011. “HOW TO GENETICALLY MODIFY A SEED, STEP BY STEP”, http://www.popsci.com/science/article/2011-01/life-cycle-genetically-modified-seed.

2 – Bravo, Kristina. 2014. “Here’s How the World’s Largest Biotech Company Came to Be”, http://www.takepart.com/article/2014/03/27/monsanto-timeline.

3 – Chassy, Bruce. 2007. “The History and Future of GMOs in Food and Agriculture”, http://www.researchgate.net/publication/249300545_The_History_and_Future_of_GMOs_in_Food_and_Agriculture

4 – Chemical Heritage Foundation. No Date. “Paul Berg, Herbert W. Boyer, and Stanley N. Cohen”, http://www.chemheritage.org/discover/online-resources/chemistry-in-history/themes/pharmaceuticals/preserving-health-with-biotechnology/berg-boyer-cohen.aspx.

5 – Gewin, Virgina. 2003. “Genetically Modified Corn – Environmental Benefits and Risks”, http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.0000008

6 – Great Smokies Medical Center. No Date. “Sources of Corn and Corn By-Products”, http://www.gsmcweb.com/sources-of-corn-and-corn-by-products/.

7 – Hauserman, Samantha. 2013. “Oswald Theodore Avery”, https://embryo.asu.edu/pages/oswald-theodore-avery-1877-1955

8 – Parrot, W. 2006. “The nature of change: Towards sensible regulation of transgenic crops based on lessons from plant breeding, biotechnology, and genomics”, Proceedings from the 17th National Agricultural Biotechnology Council.

9 – Pollack, Andrew. “US Approves Corn Modified For Ethanol”, http://www.nytimes.com/2011/02/12/business/12corn.html

10 – Shetterly, Caitlin. 2013. “The Bad Seed: The Health Risks of Genetically Modified Corn”, http://www.elle.com/beauty/health-fitness/advice/a12574/allergy-to-genetically-modified-corn/

About The Author

Chetan Hebbale is currently a graduate student at the Johns Hopkins School of Advanced International Studies (SAIS) in Washington, D.C. focused on international economics, climate change, and sustainability.

Prior to this, he spent over 4 years at Deloitte Consulting working on technology and strategy projects at the CDC and U.S. Treasury Department.

He is a native of Atlanta, GA and attended the University of Georgia.

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Climate Change Health Long Form Politics and Government

What Public Health Emergencies Can Teach Us About Climate Adaptation

We will be watching videos of life-threatening climate disasters every day on our phones until one day it’s our phone recording the next one.

Major environmental and health emergencies used to be rare, one-off occasions. Now being in a state of emergency is the new normal. Mega-hurricanes, massive floods, heat waves, inferno wildfires, even global pandemics, are now a regular part of our lives every year.

As the environment deteriorates, we will lurch from one emergency to another in a perpetual state of disaster response as the Earth becomes more and more uninhabitable every year. In order to survive humanity will have to both rely on and become our own emergency first responders.

Where we stand now is reason for pessimism. Even if we miraculously reduced all the world’s carbon emissions to zero by tomorrow we still couldn’t stop many of the environmental changes set in motion, only limit their worst effects. This is because more than 93% of the heat humans have generated is trapped in the oceans and atmosphere where it will linger for centuries.

The time for arguing about who is to blame is over. Now it’s time to figure out what happens when it’s our homes that are flooded, AC systems overwhelmed, or an even deadlier pandemic comes along.

For a few years I worked in the world of emergency response at the Centers for Disease Control (CDC). I witnessed the response to the Zika virus in the Americas, the Ebola virus in the Congo, Hurricane Maria in Puerto Rico, and most recently the COVID vaccine distribution.

In each of these emergencies, I’ve learned something new about how these shocks are handled by some of the largest public and private institutions tasked with responding. It’s this same networks of health partners and first responders who will be called upon week after week when the next disaster strikes.

This article/personal reflection is for anyone who is interested in learning more about the world of emergency response and wants tangible solutions to advocate for with their friends, family, and public officials to better prepare for humanity’s fight to survive climate change.

Lessons Learned

1. 2020 COVID – Computers call the shots.
2. 2019 Ebola – Assume people won’t listen to you.
3. 2017 Hurricane Maria – The money is there, if you know where to look.
4. 2016 Zika – Sometimes you have to make it up as you go.

Lesson #1 – Computers call the shots.

In November 2020, the Pfizer and Moderna COVID vaccines neared the finish line for FDA emergency use authorization. In preparation for nationwide distribution, the U.S. Department of Health and Human Services formed a partnership with retail pharmacy chains to administer the vaccine. Drugstores like CVS, Walgreens, and Rite-Aid were to be the frontlines of the largest vaccination campaign in human history.

It was a simple and common-sense partnership. The federal government wanted to get the widest reach possible with the lowest effort. More than a third of Americans get their annual flu shot at a pharmacy and more than 80% of Americans live within 10 miles of a CVS or other community pharmacy.

For the pharmacies, the vaccine was to be provided at no cost to them and to be administered at no cost to the recipients. The pharmacies would benefit from increased traffic in their stores as well as positive PR on their vaccination efforts.

Pharmacies like CVS formed a partnership with the federal government to distribute the COVID vaccines but faced a complex data reporting environment that delayed the roll out.

In order to become an approved pharmacy to receive the COVID vaccine they had a few rules they had to follow, namely how they would share data with the CDC on their vaccination efforts.

Every 24 hours, pharmacies had to submit data on things like how many people they vaccinated, the number of doses they ordered, and how many doses they had on hand in their inventory. This information would be fed into a larger system called Tiberius managed by Operation Warp Speed. In Tiberius, the federal government would allocate the scarce doses of the vaccine to each state based on demographics, demand, and availability.

This process working well had a lot riding on it. In December, the U.S. was in the midst of its deadliest month of the pandemic with the alpha variant from the U.K. rampantly hospitalizing and killing thousands of people every day.

Unfortunately, within the first few weeks of the vaccine rollout the wheels started to come off the track. States began complaining that the actual amount of vaccines they were allocated were far less than what they expected, in some cases more than 40% less. As a result, pharmacies and other vaccination sites in those states had to start cancelling thousands of appointments.

Washington State Governor Jay Inslee announcing the unexpected cut to the state’s COVID-19 vaccine allocation.

Our team in the CDC Vaccine Task Force was working with the pharmacies and needed to explain to them what was going on. This led us to wrapping our minds around the messy process that COVID data was coming into and out of the CDC.

The culprit was a faulty data synchronization between the CDC’s vaccine ordering system, VTrcks, and the allocation system Tiberius.

While vaccination providers were planning appointments based on what they ordered, it wasn’t until that information matched up with Tiberius that the right number of doses would arrive at their facility. The issue was diagnosed and fixed, but it held up vaccine distribution at a critical time.

USAToday did their best here.

Technology hurdles like this were one of many early missteps that were not only responsible for the U.S. ending 2020 nearly 18 million vaccinations behind schedule, but also resulted in failures to quickly identify hotspots and prevent outbreaks early in the pandemic.

The lesson is despite the best laid plans of mice and men, sometimes it’s the computers that are calling the shots. Literally. More than people agreeing on what needs to be done the harder work is ensuring that the information systems behind the scenes are also in agreement on what needs to be done. Getting the I.T. piece right can be in the biggest determinant on whether life-saving care can be administered in a timely way.

This is the largest and most important vaccine program that we have ever undertaken. We would have liked to have seen it run smoothly and have 20 million doses into people today, which was the projection. Obviously, it didn’t happen.

Dr. Anthony Fauci on the beginning of the COVID-19 vaccine rollout, December 31st, 2020

Things to advocate for:

Investing in standardized application programming interfaces (APIs) across healthcare and emergency response systems.

The two biggest challenges facing interoperability in our healthcare system today are data usability and public health data exchange delays. Health data right now are not readily available in a format that can be easily ingested and incorporated by different healthcare providers and public health systems.

More work and investment is needed in adopting the HHS Standardized application programming interface (API) for patient and population services across hospitals, laboratories, first responders, and meteorological services to make it easier for disparate systems to share information quickly in an emergency.

For years the fragmented U.S. healthcare system had struggled to become interoperable, digital, and accessible to patients when they need it most.
Development of a standardized “health passport” for individuals to manage, control, and protect their health data.

Do you know what you would do if you lost your paper vaccine card? Depending on where you live the process can be shockingly complicated to get physical or electronic proof of vaccination from your state immunization registry.

Imagine now that an immunocompromised person is brought to a large stadium for shelter after having their basement home flooded. One of more than 150 million people that will become climate refugees in the next 30 years. How will they attest to their exact prescriptions, vitals, and medical history with all their documentation under water?

Equipping individuals to have sovereignty over their own health information has been a challenge for years despite having the technology to do it in a way that protects privacy and ensures portability. Investing in a solution now that leverages advances in distributed data storage and biometrics will vastly improve healthcare in a rapid response setting.

Take Away
There will be no successful response to climate change without relying on technology. When it comes to quickly identifying and triaging an emergency situation our I.T. infrastructure needs to be nimble, portable, and interconnected – COVID has proved that it’s not there yet.


Lesson #2 – Assume people won’t listen to you.

The Ebola virus flared back up in the Congo in 2019 prompting the WHO and CDC to rush medical personnel to contain the outbreak. They feared a repeat of the 2014 outbreak that spread across West Africa, then the largest Ebola outbreak in history.

As medical staff arrived and began treating and isolating patients, they faced a series of attacks by the hardest hit communities. People began throwing stones at doctors and burning down medical facilities. One day, two gunmen barged into a medical staff meeting and opened fire.

At the time, our team at the CDC’s Division of Emergency Operations was developing resource plans for the Ebola response. The deployments of CDC health workers being processed had to be immediately cancelled until the stronger security arrangements could be made. In total, there were 386 attacks against Ebola first responders in the Congo.

Ebola Crisis In DRC Declared A Public Health Emergency
Ebola medical workers in the Congo faced skepticism and violence from those who didn’t believe the threat of the virus was real.

When asked why they were hostile to the medical workers, many responded by accusing the health workers of making up Ebola as a ruse to make money off the population. Some declared that it was a hoax perpetrated by the government to drum up foreign aid, cancel local elections and takeaway their rights. Religious officials and politicians stoked these fears.

Ebola doesn’t exist! You’ve invented the disease.

Gunman who fired on Ebola workers in the Congo

The skepticism and misinformation about Ebola bears obvious resemblance to COVID-19. Whether it was downplaying the threat of the virus, politicizing masks, watering down CDC recommendations, or letting unfounded fears of the vaccine abound, there was no shortage of conspiracies that undermined public health messaging.

The misinformation around COVID has similarly led to violence against healthcare workers and government officials. Most famously, the plot to kidnap Michigan governor Gretchen Witmer in retaliation for strict lockdown orders. Globally, hundreds of healthcare workers and contact tracers in the last year have been threatened and attacked.

This underlies a more fundamental issue with health emergencies, including climate change – successfully communicating science remains one of the most pressing challenges to overcome.

This protest against stay-at-home orders in San Diego, California like dozens around the country represent the significant communication hurdles that remain for public health emergencies.

Many times, we assume that the compelling nature of scientific assessments – especially ones that are apparent right in front of our eyes – are sufficient to spur action.

It’s smarter to assume that there will always be some countervailing political, social, or economic force which will turn the public against you, even though you are trying to help them. The imperative must be on health authorities to be proactive rather than reactive and drive the message through diverse, independent, and non-partisan channels.

Ideas to advocate for:

Partner with singers, athletes, actors, and social media influencers across the political spectrum in unified messaging campaigns.

Celebrities have a tremendous influence on the information we retain, the attitudes we adopt, and the decisions we make, including those related to our health. This is a known fact, otherwise companies wouldn’t be paying them millions of dollars to be brand ambassadors. There is already evidence that celebrities have influenced our perceptions of climate change and have driven participation in climate activism.

Leonardo DiCaprio Takes on Climate-Change Skeptics in U.N. Speech
Actor Leonardo DiCaprio speaks at the United Nations Climate Summit in 2014

In a health emergency, celebrity messages can be “especially important if trust in government/official sources is quite low,” according to Tracy Epton, a psychologist at the University of Manchester in Britain. Indeed, despite weeks of CDC warnings about the impending arrival of COVID early in 2020, the first real wakeup call for the public was when actor Tom Hanks and his wife Rita Wilson tested positive.

“Public health figures who have credibility must partner with social media influencers who have the reach. Harnessing the wide reach of local, regional and national influencers from a wide swath of sectors both within and outside of the public health community is necessary to counter the large volume of misinformation thrust into the information ecosystem.”

Dr. Amir Bagherpour and Dr. Ali Nouri – Fellow and President of the Federation of American Scientists

Response authorities should set standards on what constitutes false or misleading information in real-time, especially during a declared public health or disaster emergency.

There has been no greater driver of misinformation about scientific information than from social media. What many have called an “infodemic“, a deluge of fake news about the virus circulates on platforms like Facebook, WhatsApp, Twitter and YouTube at a dizzying velocity.

These companies are reactive rather than proactive and slow to flag or remove content before thousands have already seen them. Last April, 59% of posts about COVID rated as false by fact-checkers remained up on Twitter. On YouTube, 27% remained up and on Facebook 24% of false-rated content remained up without warning labels.

There is a strong association between the use of WhatsApp and Facebook and believing COVID misinformation.

September 2020 joint study from Harvard, Northwestern, Rutgers and Northeastern universities on COVID misinformation

Disaster response officials must form stronger partnerships with social media companies to identify common sources of misinformation and enable speedy removal. With the poor track record of tech companies being able to self-regulate, response authorities may need the power to remove content in real-time, especially at the early stages of an emergency.

How to Block Social Media Apps From Yourself
Misinformation on social media has been one of the principle forces derailing key public health messages on COVID.
Learn from the advertising industry on how to identify, engage, and influence the behavior of your target audience.

The ad industry is incredibly powerful because of its ability to understand the preferences of its audience and use them to subtly influence, even manipulate people into taking a desired decision. Credit their innovative use of behavioral economics, marketing analytics, and empowered creative departments.

While public health mass media campaigns have worked successfully on issues like reducing smoking, there is clearly much to be learned in terms of how to change individual behavior in the context of a health emergency. Recruiting from and partnering with the top advertising and public relations firms could provide some fresh thinking and new tools on better ways to win over the audience and nudge the public to prepare more proactively for climate change.

Take Away
Misinformation and conspiracies derail every public health emergency – science can’t be expected to be listened to on its own merits. For scientific guidance to be communicated more effectively there needs to be a re-thinking on the public faces of an emergency, the tactics to remove false information online, and how best to target and influence the average citizen.


Lesson #3 – The money is there, if you know where to look.

On September 20th, 2017, a high-end Category 4 hurricane slammed into Puerto Rico. Hurricane Maria flattened entire neighborhoods causing unprecedented damage to structures, roads, the power grid, and healthcare facilities. The entire population of 3.7 million people was left without electricity overnight.

More than 100,000 Puerto Ricans did not have clean food, water, or reliable electricity for more than 6 months. It is considered the worst natural disaster in history to hit the island.

Three consecutive mega-hurricanes approach the U.S. in 2017 tearing through the Caribbean, Puerto Rico, and the southern U.S.

The response from the U.S. government was haphazard to say the least. Part of the reason was that this was the third consecutive mega-hurricane to hit the U.S. in a stretch of a few weeks: Hurricane Harvey, Irma, and now Maria. This precarious situation left FEMA, CDC, and other emergency response agencies even more strapped for resources.

The Trump administration was not only slow to take the crisis in Puerto Rico as seriously as the recovery efforts in Florida and Texas, but badly bungled the logistics and operations of getting relief to the island. This even prompted a personal feud between Trump himself and the mayor of San Juan.

Ultimately, Puerto Rico received 1/9th of the emergency meals, half the amount of water supplies, and 1/20th of the tarps provided during the responses to Harvey and Irma.

The Department of Homeland Security Office of Inspector General found that FEMA “lost visibility” or failed to fully track nearly 40% of shipments to Puerto Rico with a value of nearly $257 million in meals, water, blankets and other supplies.

ABC News

It was in this environment that our team at the CDC’s Office of Financial Resources was tasked to find money, wherever it may exist within the agency, to help fund the public health emergency response operation in Puerto Rico.

One thing I quickly learned on this fiscal hunting trip is how much government money goes unused every year. When federal agencies don’t spend the funds Congress appropriates to them within a specific timeframe, the funds are “cancelled” and returned to the U.S. Treasury Department General Account (known as the TGA).

Once funds are cancelled, they are legally not allowed to be used for anything else. According to a Government Accountability Office (GAO) study, roughly $24 billion dollars in government-wide budget authority is cancelled every year – enough to pay for an annual universal pre-K program.

The reasons for canceling government appropriations can vary. Sometimes agencies just run out of time to implement a program. Many times, they simply don’t have the capacity to effectively find organizations, projects, or things to buy to use up their appropriated funds.

President Trump tosses paper towels to a crowd at a press conference in a Puerto Rican relief center

Before having to cancel appropriated funds, some agencies have authority to redirect this money for other purposes – this is a process known as “re-programming”.

One specific spending mechanism we looked into for the possibility of reprogramming was “unliquidated obligations”. Basically, the government agreed to set aside money to pay for some purpose (obligation) but ended up not incurring any expenses for that purpose.

After diving deeper into the numbers, we uncovered $6 billion in unliquidated obligations on the CDC’s accounting books. Money that could be re-programmed not just for the response in Puerto Rico, but several other public health operations.

Ideas to advocate for:

In a recent GAO study almost 70% of the agency officials interviewed reported that they ended up cancelling unused government funds because they could only be used for very specific purposes and did not have the legal authority to re-direct them to related/adjacent activities.

Rather than returning the money, agency officials need increased acquisition flexibilities, increases to warrant thresholds, new approving authorities, expansion to purchase card flexibilities, and the ability to use Inter-Departmental Delegation Authority (IDDA) and Inter-Agency Agreements (IAAs). These tools will give policymakers enhanced flexibility to respond to health emergencies in a forceful way.

Otherwise, agencies need to go through a process of review and congressional notification to take re-programming actions which can take several months. Because of the “use-it-or-lose-it” nature of these appropriations, a flurry of federal spending happens in the last week of the government fiscal year (last week of September) even if it results in lower quality projects or for issues that are not as urgent.

Federal agencies spend an average of 4.9 times more in the last week of their fiscal year than in a typical week during the rest of the year

National Bureau of Economic Research
Direct the Office of Management and Budget (OMB) to target undisbursed balances by streamlining the project closeout process.

Nearly a fifth of all government spending (~$800B) goes to disbursing grants. The very first work project I worked on was helping manage the Public Health Emergency Preparedness (PHEP) grant throughout all its phases: pre-award, award, implementation, and closeout.

The closeout portion of a grant’s lifecycle is where a lot of the hidden money may lie. Closeout procedures are designed to ensure that the grantee has satisfied the terms of the grant and submitted all required financial and performance reports to the awarding agency. In this process, money that was given to a grantee but was never actually used is often discovered. That’s not always the case though.

In 2011, the GAO identified that the total amount of unused grant money can represent anywhere from 2.7% to a jaw-dropping 34.8% of an agency’s or program’s grant funding. More than $794 million in funding remaining in expired grant accounts for just one agency. Stronger action to improve systems and policies for reconciling payment accounts and monitoring grantee spending can be critical to maximizing available dollars to respond to emergencies.

Take Away
Disasters and emergencies are the last time you want to be getting thrifty. Rather than asking “how are you going to pay for it?” realize that we probably have already paid for it! Millions of dollars are sitting in unused or expired accounts or are being returned to the government because of lack of capacity and poor management. Granting increased flexibility to use government funds and rooting out idling money during a project’s “closeout” phase can refill coffers when responding to multiple, concurrent emergencies.


Lesson #4 – Sometimes you’re going to make it up as you go.

As the Zika virus began to spread across the Western Hemisphere in 2016 there was a scramble for reproductive health experts. Pregnant women infected with Zika were having babies born with deformed brains – a condition so terminal that women in South America were encouraged to postpone pregnancy for almost a year.

The CDC’s National Center of Birth Defects and Developmental Disabilities was called up to lead the emergency response at the agency. Unfortunately, most of the experts from the Center had no previous emergency response experience.

Early on epidemiologists were being asked to design communications flyers. Clinicians had figure out how to finance a laboratory task force. Unsurprisingly, things were delayed getting out the door to the populations that needed them most.

Zika was inducing a birth defect known as microcephaly – where a baby’s brain would not be fully developed – a condition with no known cure.

Staffing during an emergency response requires careful planning and tracking. But more often than not, at the beginning of a crisis an ad-hoc team of subject matter experts and support staff are pulled together, some of whom who may have never been trained for the unique environment of emergencies.

Because of the speed and voluntary nature of recruitment, skill sets are often misaligned or altogether missing for the precise needs of the response. This results in those on the frontline having to learn on the job at a time when inefficiencies and mistakes can have lethal consequences.

Ideas to advocate for:

Predict your needed workforce rather than reacting.

The U.S. has been in enough emergencies to know roughly what to expect whether it’s a domestic natural disaster or international pandemic response. By mining data from previous responses on information like: the number of people deployed, the roles needed, length of deployment, etc. agencies can create a predictive workforce based on specific emergency scenarios. This approach would not only enable more rapid identification of the right people when standing up a response but getting ahead of training those who have not been in a response before but have a frequently needed skillset.

Create a public health reserve – a gig workforce of dedicated emergency responders.

Disaster response agencies could develop a roster of response alumni and on-call workers that can be rapidly deployed without having to pull staff from other departments. This public health reserve would be similar to a “bench” in the management consulting industry but filled with government employees and volunteer citizens whose main role is to be emergency response specialists.

Versions of this exist currently in different cities known as a Medical Reserve Corp (MRC). MRCs were crucial in recruiting citizen volunteers to assist in COVID vaccination efforts. I was able to join the Fulton County MRC in Atlanta and assist in the logistics at Mercedes-Benz stadium (and luckily got my first dose out of it).

Exercise-based training for preparing laboratory samples for staff who have not been part of an emergency response before.
Make emergency exercise-based trainings mandatory for all health domains.

Many believe an emergency will not happen to them in their specific field and thus pass up the voluntary trainings on emergency operations. Zika struck reproductive health, COVID came for respiratory health, in which health domain will the next crisis strike? There’s no way to know, which is why these trainings should be mandatory and regularly exercised across health domains with an eye towards high priority scenarios, like:

  • Pandemic influenza
  • Vector-borne diseases (e.g., malaria, bubonic plague)
  • Natural disasters (e.g., hurricanes, wildfires)
  • Environmental hazards (e.g., chemical/oil spills, radiological incidents)

These trainings should be supplemented with YouTube-like clip series of short, discrete, actionable lessons would be designed to provide guidance and reinforce necessary skills in less than 5 minutes (e.g., how to use a test kit or fill out a report, etc.)

Take Away
Public health or medical expertise does not always translate to disaster response expertise. The most critical impact of inadequate training and staffing during an emergency response is that lives are at risk. Response staff needs access to the knowledge and support required to be prepared for their role and be able to deploy the necessary skills as soon as possible.


Conclusion

While the world is still caught up in the COVID-19 pandemic, it’s critical that we do not view this in isolation of the larger ecological crisis at play between nature and humans.

While our imagination may be limited to floods and wildfires, mosquito-borne diseases like malaria and Zika will become more prevalent as the planet’s hot zone around the equator expands by 5.5 feet everyday. Pathogens, dormant for centuries in the Arctic permafrost, are being released as the ice melts.

Regardless of where the threat comes from, the lives of billions of people will be at the whim of how effectively their government can marshal the necessary resources to put out the next fire (in a very real sense).

Firefighters in Greece rush to put out raging wildfires this summer amidst their most serious heatwave in 30 years.

When it comes to disaster and emergency response, most of us have no idea where to begin. And no, stop-drop-and-roll does not really count. For those on the front lines of responding, there is little time to look back – the next emergency is already upon them. The strain of a constant cycle of emergency activations and deployments have drained our public health and disaster response authorities. They need our help.

Responsible citizens have an opportunity and an obligation to demand action on the longstanding inefficiencies in our emergency response operations. If left unaddressed, they will continue to rear their head when the world can least afford them.

About The Author

Chetan Hebbale is currently a graduate student at the Johns Hopkins School of Advanced International Studies (SAIS) in Washington, D.C. focused on climate and sustainability.

Prior to this, he spent over 4 years at Deloitte Consulting working on technology and strategy projects at the CDC and U.S. Treasury Department.

He is a native of Atlanta, GA and attended the University of Georgia.

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Health Politics and Government

Inside the CDC’s Vaccine Distribution Plan

A guide to understand the rollout of the COVID-19 vaccine.

About The Author

Chetan Hebbale is currently a graduate student at the Johns Hopkins School of Advanced International Studies (SAIS) in Washington, D.C. focused on international economics, climate change, and sustainability.

Prior to this, he spent over 4 years at Deloitte Consulting working on technology and strategy projects at the CDC and U.S. Treasury Department.

He is a native of Atlanta, GA and attended the University of Georgia.

Read More:

Categories
Health Politics and Government

Summary of Biden’s COVID-19 National Strategy and Executive Orders

Overview of the COVID-19 National Strategy

The National Strategy outlines an actionable plan across the federal government to address the COVID-19 pandemic, including twelve executive actions issued by President Biden on his first two days in office.

The National Strategy is organized around seven goals:

  1. Goal 1: Restore trust with the American people by establishing a national COVID-19 response structure, conducting regular expert-led public briefings, publicly sharing data around key response indicators, and engaging the public through outreach, townhalls, and roundtables. Immediate actions on this goal include:
    1. Executive Order on Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security.
  • Goal 2: Mount a safe, effective, and comprehensive vaccination campaign by boosting supply of vaccines, ramping up vaccination sites and the public health workforce, focusing on high-risk populations and equity of distribution, improving data collection and transparency, and launching a public education campaign to combat vaccine hesitancy. Immediate actions on this goal include:
  • Goal 3: Mitigate spread through expanding masking, testing, data, treatments, health care workforce, and clear public health standards. This will be achieved by implementing mask requirements nationwide, scaling and expanding testing, prioritizing promising therapeutics, hiring more public health workers, and improving data quality. Immediate actions on this goal include:  
    • Executive Order on Protecting the Federal Workforce and Requiring Mask-Wearing.
    • Executive Order on Promoting COVID-19 Safety in Domestic and International Travel.
    • Executive Order on Establishing the National Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce for COVID-19 and other Biological Threats.
    • Executive Order on Ensuring a Data-Driven Response to COVID-19 and Future High Consequence Public Health Threats.
    • Executive Order on Improving and Expanding Access to Care and Treatments for COVID-19.
  • Goal 4: Immediately expand emergency relief and exercise the Defense Production Act which can be used to fill vaccine and PPE supply shortfalls, strengthen and secure the supply chain, improve distribution, and pull in FEMA to stand up more vaccination sites. Immediate actions on this goal include:
    • Presidential Memorandum to Extend Federal Support to Governors’ Use of National Guard to Respond to COVID-19 and to Increase Reimbursement and other Assistance Provided to States
  • Goal 5: Safely reopen schools, businesses, and travel while protecting workers by implementing a national strategy that includes access to FEMA relief funds for PPE, expanded testing, sharing of best practices across schools for an equitable re-opening, enforcement of worker safety laws along with expanding paid leave, and providing consistent technical guidance. Immediate actions on this goal include:
    • Executive Order on Supporting the Reopening and Continuing Operation of Schools and Early Childhood Education Providers
    • Executive Order on Promoting COVID-19 Safety in Domestic and International Travel
  • Goal 6: Protect those most at risk and advance equity, including across racial, ethnic and rural/urban lines by establishing a Health Equity Task Force, increase data collection and reporting on high-risk communities, provide equitable access to PPE, tests, and vaccines, launch a new community-based Public Health workforce program, and strengthen social safety nets. Immediate actions on this goal include:
  • Goal 7: Restore U.S. leadership globally and build better preparedness for future threats by strengthening the WHO, joining multilateral efforts on R&D and vaccine sharing, build better bio-preparedness through an an international biological response framework and establishing a National Center for Epidemic Forecasting and Outbreak Analytics, and leading on humanitarian support with international financial institutions. Immediate actions on this goal include:
    • National Security Directive on United States Global Leadership to Strengthen the International COVID-19 Response and to Advance Global Health Security and Biological Preparedness

Full Text of National Strategy


Executive Order on Promoting COVID-19 Safety in Domestic and International Travel

Immediate Action to Require Mask-Wearing on Certain Domestic Modes of Transportation.

  • The Secretary of Labor, HHS Secretary, Transportation Secretary and DHS Secretary will immediately take action to require and incentivize masks to be worn in or on: airports, commercial aircraft, trains, public maritime vessels, including ferries, intercity bus services; and all forms of public transportation as defined in section 5302 of title 49, United States Code. They may also provide recommendations on how their agency can impose additional public health measures for domestic travel

International Travel

  • Within 14 days of this order (Friday, February 4th), the Secretary of State, HHS Secretary, CDC Director, Transportation Secretary, and DHS Secretary will:
    • Assess the ability to enforce the requirement of a negative COVID-19 test for airline passengers traveling into the U.S., including the type of proof needed
    • Determine measures to prevent fraud of a negative test
    • Assess the ability to provide alternate measures for those coming from countries with a lack of ability to get tested, including self-quarantine or self-isolation on arrival
    • Submit plans to implement appropriate public health measures at land and sea ports of entry
  • The Secretary of State, HHS Secretary, and DHS Secretary will assess the feasibility of linking COVID-19 vaccination to International Certificates of Vaccination or Prophylaxis (ICVP) and producing electronic versions of ICVPs

Full Text


Executive Order on Improving and Expanding Access to Care and Treatments for COVID-19

Accelerating the Development of Novel Therapies

  • HHS Secretary and NIH Director will develop a plan for supporting studies to identify optimal clinical management strategies and for supporting treatments for COVID-19 that can be easily manufactured, distributed, and administered. These studies will support research in:
    • Rural hospitals and other rural locations
    • The long-term impact of COVID-19
    • Including underrepresented populations in clinical trials  

Improving the Capacity of the Nation’s Healthcare Systems to Address COVID-19

  • Defense Secretary, HHS Secretary, and VA Secretary will:
    • Provide targeted surge assistance to critical care and long-term care facilities, including nursing homes and skilled nursing facilities, assisted living facilities, intermediate care facilities for individuals with disabilities, and residential treatment centers
    • Establish targets for the production, allocation, and distribution of COVID-19 treatments and prioritize investments in therapeutics that can be readily administered and scaled

Improving Access to Quality and Affordable Healthcare

  • HHS Secretary will:
    • Identify barriers to maximizing the effective and equitable use of existing COVID-19 treatments and provide support to State, local, Tribal, and territorial authorities to overcome them
    • Evaluate the COVID-19 Uninsured Program operated by HRSA to promote access to treatments and clinical care for those without adequate coverage
    • Evaluate Medicare, Medicaid, group health plans, and health insurance issuers, and take any available steps to promote insurance coverage for safe and effective COVID-19 treatments and clinical care
    • Issue recommendations on how States and healthcare providers can increase the capacity of their healthcare workforces
    • Work with HRSA and SAMSHA to expand access to programs and services designed to meet the long-term health needs of patients recovering from COVID-19

Full Text


Executive Order on Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats

Enhancing Data Collection and Collaboration Capabilities for High-Consequence Public Health Threats, Such as the COVID-19 Pandemic

  • Defense Secretary, Attorney General, HHS Secretary, Education Secretary, OMB Director, Director of National Intelligence, Director of White House Office of Science Technology and Policy (OSTP) will designate a senior official to serve as their agency’s lead to work on COVID-19- and pandemic-related data issues
  • OMB, OSTP and U.S. CTO will issue supplemental guidance concerning how to de-identify COVID-19-related data and how to make data open to the public in human and machine-readable formats as rapidly as possible
  • OMB director will review and provide assistance in the ability of agencies to hire personnel expeditiously into roles related to information technology and the collection, provision, analysis, or other use of data to address high-consequence public health threats
  • White House COVID-19 Response Coordinator will coordinate the relevant agencies in their collection, provision, and analysis of data, including key equity indicators, regarding the COVID-19 response, as well as their sharing of such data with State, local, Tribal, and territorial authorities.

Public Health Data Systems

  • HHS Secretary will:
    • Review the effectiveness, interoperability, and connectivity of public health data systems
    • Review the collection of morbidity and mortality data by State, local, Tribal, and territorial governments
    • Issue a report summarizing the findings of the reviews and any recommendations for addressing areas for improvement

Advancing Innovation in Public Health Data and Analytics

  • Director of OSTP, in coordination with the National Science and Technology Council shall develop a plan for advancing innovation in public health data and analytics in the United States

Full Text


Memorandum to Extend Federal Support to Governors’ Use of the National Guard to Respond to COVID-19 and to Increase Reimbursement and Other Assistance Provided to States

By invoking the powers in the Stafford Act and section 502 of title 32, the President orders:

  • The Secretary of Defense to request all State and territorial governors order National Guard forces to perform duty to fulfill mission assignments for the purpose of supporting State, local, Tribal, and territorial emergency assistance efforts
  • FEMA to fund 100% of the cost of activities associated with all mission assignments for the use of the National Guard
  • FEMA will provide assistance for the safe opening and operation of eligible schools, child-care facilities, healthcare facilities, non-congregate shelters, domestic violence shelters, transit systems, and other eligible applicants.
    • This assistance is available at a 100% Federal cost share until September 30, 2021.
    • FEMA will expedite reimbursement for eligible emergency work projects

Full Text


Executive Order on a Sustainable Public Health Supply Chain

Immediate Inventory of Response Supplies and Identification of Emergency Needs and Pandemic Supply Chain Resilience Strategy

  • Secretary of State, Defense Secretary, HHS Secretary and DHS Secretary will:
    • Review the availability of critical materials, treatments, and supplies (including PPE and resources to distribute tests and vaccines at scale)
    • Assess whether the U.S. industry can provide such supplies in a timely manner
    • Use the Defense Production Act to fill shortfalls in those supplies by acquiring additional stockpiles, improving distribution systems, building market capacity, or expanding the industrial base
    • Within 180 days of this order (Tuesday, July 20th) – provide to the President a strategy to design, build, and sustain a long-term capability in the United States to manufacture supplies for future pandemics and biological threats

Pricing and Access to Strategic National Stockpile

  • HHS Secretary will:
  • Provide recommendations to the President for how to address the pricing of pandemic response supplies
  • Assess scarce materials or materials the supply of which would be threatened by accumulation for the purpose of hoarding or price gouging
  • Provide a report to the President on the status and inventory of the Strategic National Stockpile
  • Facilitate access to the Strategic National Stockpile for federally recognized Tribal governments, Indian Health Service healthcare providers, Tribal health authorities, and Urban Indian Organizations

Full Text


Executive Order on Ensuring an Equitable Pandemic Response and Recovery

COVID-19 Health Equity Task Force

  • Establish a COVID-19 Health Equity Task Force in HHS to provide recommendations to the President on:
    • How agencies and State, local, Tribal, and territorial officials can best allocate COVID-19 resources
    • How to disburse funds in a manner that advances equity
    • Effective, culturally aligned communication, messaging, and outreach to communities of color and other underserved populations
    • Factors that contributed to disparities in COVID-19 outcomes, and recommending actions to combat such disparities
    • Expediting data collection for communities of color and other underserved populations
    • Addressing these data shortfalls and other foundational data challenges, including those relating to data intersectionality

Ensuring an Equitable Pandemic Response

  • Agriculture Secretary, Labor Secretary, HHS Secretary, HUD Secretary, Education Secretary, and EPA Administrator will:
    • Consult with the Health Equity Task Force to strengthen equity data collection, reporting, and use related to COVID-19
    • Assess pandemic response plans and policies to determine whether personal protective equipment, tests, vaccines, therapeutics, and other resources have been or will be allocated equitably
    • Modify pandemic response plans based on policy priorities expressed by communities that have suffered disproportionate rates of illness and death
    • Strengthen enforcement of anti-discrimination requirements pertaining to the availability of, and access to, COVID-19 care and treatment
    • Partner with States, localities, Tribes, and territories to provide greater assistance including expanding access to food, housing, child care, or income support
  • HHS Secretary will:
    • Provide recommendations to State, local, Tribal, and territorial leaders on how to facilitate the placement and recruitment of contact tracers and other workers in the hardest hit communities
    • Conduct an outreach campaign to promote vaccine trust and uptake among communities of color and other underserved populations with higher levels of vaccine mistrust

Full Text


Executive Order on Supporting the Reopening and Continuing Operation of Schools and Early Childhood Education Providers

Agency Roles and Responsibilities

  • The Secretary of Education will:
    • Provide evidence-based guidance to assist States, elementary and secondary schools and institutes of higher education in deciding whether and how to reopen, and how to remain open. This will be done in consultation with the HHS Secretary.
    • Provide advice on distance and online learning, blended learning, and the promotion of mental health and social-emotional well-being
    • Develop a Safer Schools and Campuses Best Practices Clearinghouse to enable schools and institutions of higher education to share lessons learned and best practices for operating safely during the pandemic
    • Direct the Assistant Secretary for Civil Rights to deliver a report on the on the disparate impacts of COVID-19 on education for underserved populations
    • Coordinate with the Director of the Institute of Education Sciences to collect data necessary to fully understand the impact of the COVID-19 pandemic on students and educators
    • Work with the HHS Secretary to submit a report to the Assistant to the President for Domestic Policy and the COVID-19 Response Coordinator identifying strategies to address the impact of COVID-19 on educational outcomes, especially along racial and socioeconomic lines
  • HHS Secretary will:
    • Facilitate the collection of data needed to inform the safe reopening and continued operation of schools
    • Ensure that COVID-19-related supplies, including testing materials, are equitably allocated to elementary and secondary schools
    • Support the development and operation of contact tracing programs to facilitate school reopenings
    • Provide guidance on cleaning, masking, proper ventilation, and testing,
  • Federal Communications Commission (FCC) is encouraged to increase connectivity options for students lacking reliable home broadband

Full Text


Executive Order on Protecting Worker Health and Safety

Protecting Workers from COVID-19 Under the Occupational Safety and Health Act (OSHA)

  • The Labor Secretary will:
    • Within 2 weeks of this order (Friday, February 4th) issue revised guidance to employers on workplace safety during the COVID-19 pandemic
    • Consider whether any emergency temporary standards on COVID-19 (e.g. masks) are necessary and issue them by March 15th, 2021, including for coal, metal or non-metal mines
    • Review enforcement of OSHA and identify changes that could be made to better protect workers and ensure equity in enforcement
    • Launch a national program to focus OSHA enforcement efforts related to COVID-19 on violations that put the largest number of workers at serious risk or are contrary to anti-retaliation principles
    • Work with states and local government and public employee unions to bolster protection from COVID-19 in states that don’t have occupational health and safety plans approved by OSHA
  • Agriculture Secretary, Labor Secretary, HHS Secretary, Transportation Secretary, and Energy Secretary will explore mechanisms to protect workers not protected under OSHA so that they remain healthy and safe on the job during the COVID-19 pandemic

Full Text


National Security Directive on United States Global Leadership to Strengthen the International COVID-19 Response and to Advance Global Health Security and Biological Preparedness

Strengthening and Reforming the World Health Organization

  • Within 30 days of this directive (February 21st, 2021), the Assistant to the President for National Security Affairs, Secretary of State and HHS Secretary will provide to the President recommendations on how the U.S. can:
    • Exercise leadership at the WHO and work with partners to lead and reinvigorate the international COVID-19 response
    • Participate in international efforts to advance global health, health security, and the prevention of future biological catastrophes
    • Otherwise strengthen and reform the WHO

United States Leadership in the Global Response to COVID-19

  • Secretary of State and HHS Secretary will:
    • Inform the WHO and Gavi, the Vaccine Alliance, of the United States’ intent to support the Access to COVID-19 Tools (ACT) Accelerator and join the multilateral vaccine distribution facility, known as the COVID-19 Vaccine Global Access (COVAX) Facility 
    • Develop a framework for donating surplus vaccines, once there is sufficient supply in the U.S.
    • Develop a plan for engaging with and strengthening multilateral initiatives focused on the global COVID-19 response, including equitable development and distribution of vaccines, therapeutics, tests, and personal protective equipment
  • Secretary of State, HHS Secretary, USAID Administrator, and CDC Director will:
    • Submit a Government-wide plan to combat the global COVID-19 pandemic, which shall identify principal strategic objectives, corresponding lines of effort, and lead agencies.
    • Review and, as necessary, adjust the United States’ current and planned future deployments of public health, health security, and health diplomacy personnel overseas focused on the COVID-19 response
    • Within 14 days of this directive (Friday, February 4th) and in consultation with the Ambassador to the UN, develop a diplomatic outreach plan for enhancing the United States’ response to the COVID-19 pandemic, with a focus on engaging partner nations, the United Nations, and other multi-lateral stakeholders on:
      • The financing of and capacity for strengthening the global COVID-19 response
      • Assistance to mitigate the secondary impacts of the pandemic such as food insecurity and gender-based violence and supporting vulnerable communities
  • Secretary of State, Treasury Secretary, Commerce Secretary, HHS Secretary, and USAID Administrator will review existing United States and multilateral financial and economic sanctions to evaluate whether they are unduly hindering responses to the COVID-19 pandemic and provide recommendations for any changes

Review of Funding for COVID-19 Response and Global Health Security and Biodefense

  • OMB Director will review the funding allocated for the COVID-19 response, including the secondary impacts of the pandemic, as well as for global health security, global health, pandemic preparedness, and biodefense and provide the President with an assessment if it is enough 

Financing for Global Health Security

  • Secretary of State, Treasury Secretary, HHS Secretary, USAID Administrator, CEO of the United States International Development Finance Corporation, and Assistant to the President for National Security Affairs will promptly provide to the President recommendations for creating an enduring international catalytic financing mechanism for advancing and improving existing bilateral and multilateral approaches to global health security
    • Treasury Secretary will separately provide a strategy to the President for how the U.S. can promote financing, relief, and other policies that are aligned with and support the goals of combating COVID-19 and strengthening global health security in international financial institutions, including the World Bank Group and International Monetary Fund

Advancing Global Health Security and Epidemic and Pandemic Preparedness

  • Assistant to the President for National Security Affairs will
    • Coordinate the Federal Government’s efforts to prepare for, prevent, detect, respond to, and recover from biological events
    • Elevate United States leadership and assistance in support of, the Global Health Security Agenda
    • Develop recommendations for how the Federal Government will update existing health security policies and strategies, including:
      • Developing stronger global institutions focused on harmonizing crisis response for emerging biological events and public health emergencies
      • Taking steps to strengthen the global pandemic supply chain and address any barriers to the timely delivery of supplies in response to a pandemic
      • Working with partner countries and international organizations to strengthen and implement the International Health Regulations
      • Reducing racial and ethnic disparities in the COVID-19 global response and disproportionate impacts on marginalized and indigenous communities, women and girls, and other groups
      • Reviewing and developing priorities for multilateral fora aimed at reducing the risk of deliberate or accidental biological events
      • Combating antimicrobial resistance
      • Fighting climate change as a driver of health threats
    • Coordinate with the Secretary of State, HHS Secretary, USAID Administrator, and CDC Director to develop  protocols for coordinating and deploying a global response to emerging high-consequence infectious disease threats, including establishing standard operating procedures for how USAID and the CDC coordinate their response efforts.
    • Coordinate with the COVID-19 Response Coordinator and Assistant for the President for Domestic Policy to develop a plan for establishing an interagency National Center for Epidemic Forecasting and Outbreak Analytics and modernizing global early warning and trigger systems for scaling action to prevent, detect, respond to, and recover from emerging biological threats
    • Coordinate with the Secretary of State and UN Ambassador to support the establishment of a new position in the office of the United Nations Secretary-General of a facilitator for high-consequence biological threats
  • The Director of National Intelligence will:
    • Develop a plan for how the intel community may strengthen and prioritize collection and reporting capabilities of pandemics, including through organizational changes or the creation of National Intelligence Manager and National Intelligence Officer positions focused on biological threats, global public health, and biotechnology
    • Submit to the president a  National Intelligence Estimate on the impact of COVID-19 on national and economic security; and current, emerging, reemerging, potential, and future biological risks to national and economic security
    • Coordinate with the HHS Secretary, Defense Secretary, CDC Director, USAID Administrator, and OSTP Director to develop an analysis of the security implications of biological threats that can be incorporated into modeling, simulation, course of action analysis, and other analyses

Full Text


Executive Order on Establishing the COVID-19 Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce for COVID-19 and Other Biological Threats

COVID-19 Pandemic Testing Board

  • By invoking section 301 of title 3, United States Code, the President orders the establishment of a COVID-19 Pandemic Testing Board chaired by the COVID-19 Response Coordinator which shall:
  • Coordinate efforts to promote COVID-19 diagnostic, screening, and surveillance testing
  • Make recommendations to expand testing, genomic sequencing, and reduce disparities in access to testing for priority populations, communities with shortages in testing, at-risk settings, and high-risk groups
  • Maximize testing capacity of commercial labs and academic labs

Actions to Address the Cost of COVID-19 Testing

  • Treasury Secretary, HHS Secretary, Labor Secretary, and COVID-19 Response Coordinator will:
    • Facilitate the provision of COVID-19 testing free of charge to those who lack comprehensive health insurance
    • Clarify group health plans’ and health insurance issuers’ obligations to provide coverage for COVID-19 testing
  • HHS Secretary, Education Secretary, DHS Secretary, including FEMA will:
    • Provide support for surveillance tests for settings such as schools
    • Expand equitable access to COVID-19 testing

Establishing a Public Health Workforce Program

  • HHS Secretary and Labor Secretary will:
    • Consult provide technical support to State, local, Tribal, and territorial leaders in their challenges for pandemic response efforts, including challenges recruiting and training sufficient personnel for testing, contact tracing, and mass vaccinations and combating opioid use
    • Develop a plan for how HHS would deploy personnel in response to future public health threats
    • Establish five-year targets and budget requirements for achieving a sustainable public health workforce, including expanding the U.S. Public Health Service Commissioned Corps and Epidemic Intelligence Service
  • HHS Secretary, DHS Secretary, Labor Secretary, Education Secretary, and Chief Executive Officer of the Corporation for National and Community Service will establish a U.S. Public Health Job Corps modeled on the FEMA Corps program which will:
    • Train individuals in contact tracing and testing related to the COVID-19 pandemic;
    • Assist in outreach for vaccination efforts, including by administering vaccination clinics

Full Text


Executive Order on Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security

Organizing the White House to Combat COVID-19

  • Established within the Executive Office of the President the position of Coordinator of the COVID-19 Response and Counselor to the President (COVID-19 Response Coordinator) and a Deputy who will be responsible for coordinating the government-wide effort to curb the pandemic including:
    • Reducing disparities in the response, care, and treatment of COVID-19, including racial and ethnic disparities;
    • Coordinating efforts to produce, supply, and distribute personal protective equipment, vaccines, tests, and other supplies including through the use of the Defense Production Act
    • Expanding COVID-19 testing and the use of testing as an effective public health response
    • Supporting the timely, safe, and effective delivery of COVID-19 vaccines to the United States population;
    • Supporting the safe reopening and operation of schools, child care providers, and Head Start programs

United States Leadership on Global Health and Security and the Global COVID-19 Response

  • Assistant to the President for National Security Affairs will convene the National Security Council Principals Committee to address and advise on matters regarding:
    • The intersection of the COVID-19 response and other national security equities
    • Global health security
    • Engaging with and strengthening the World Health Organization
    • Public health, access to healthcare, and the secondary impacts of COVID-19;
    • Emerging biological risks and threats
  • Within 180 days of this order (Monday, July 19th), this group will  complete a review of and recommend actions to the President concerning emerging domestic and global biological risks and national biopreparedness policies
  • Re-Establish the NSC Directorate on Global Health Security and Biodefense for monitoring current and emerging biological threats

Full Text


Executive Order on Protecting the Federal Workforce and Requiring Mask-Wearing

Immediate Action Regarding Federal Employees, Contractors, Buildings, and Lands

  • The heads of executive departments and agencies shall immediately take action to require compliance with CDC guidelines with respect to wearing masks, maintaining physical distance for all persons in Federal buildings or on Federal lands.

Encouraging Masking Across America

  • HHS Secretary and CDC Director will engage with State, local, Tribal, and territorial officials, as well as business, union, academic, and other community leaders with the goal of maximizing public compliance with, and addressing any obstacles to, mask-wearing

Safer Federal Workforce Task Force

  • Establish the Safer Federal Workforce Task Force which shall provide ongoing guidance to heads of agencies on the latest CDC guidance regarding:
    • Testing methodologies, case investigation and contact tracing;
    • Requirements of and limitations on physical distancing, including recommended occupancy and density standards;
    • Equipment needs and requirements, including personal protective equipment
    • Air filtration
    • Enhanced environmental disinfection and cleaning;
    • Safe commuting and telework options
    • Enhanced technological infrastructure to support telework
    • Vaccine prioritization, distribution, and administration;
    • Approaches for coordinating with State, local, Tribal, and territorial health officials
    • Management infrastructure needed to implement public health guidance

Federal Employee Testing

  • CDC Director and HHS Secretary will develop a testing plan for the Federal workforce

Research and Development

  • Director of OSTP, HHS Secretary, OMB Director, CDC Director, NIH Director, and NSF Director will assess the availability of Federal research grants to study best practices for implementing, and innovations to better implement, effective mask-wearing and physical distancing policies, with respect to both the Federal workforce and the general public

Full Text

About The Author

Chetan Hebbale is currently a graduate student at the Johns Hopkins School of Advanced International Studies (SAIS) in Washington, D.C. focused on international economics, climate change, and sustainability.

Prior to this, he spent over 4 years at Deloitte Consulting working on technology and strategy projects at the CDC and U.S. Treasury Department.

He is a native of Atlanta, GA and attended the University of Georgia.

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Categories
Essay Review Health

Curing COVID: Drugs And Vaccines Are Coming, But To Whom?

Synopsis of key findings from essay written in Foreign Affairs May 2020

Jennifer Hillman: Professor of Practice at the Georgetown University Law Center having previously served as a Commissioner on the U.S. International Trade Commission and one of 7 judges on the World Trade Organization’s (WTO) Appellate Body.


Race For A Cure

  • COVID-19 will be the largest vaccine and anti-viral drug deployment in human history. The world cannot fully emerge from lockdown until billions of people have access to both vaccines and anti-virals. Vaccines provide immunity and prevent future infections, while anti-virals treat already sick patients by halting viral replication.
  • Eight vaccine candidates have reached or are approaching clinical trial stage, and more than 70 anti-viral medication trials are underway. The leading vaccines are from Oxford University & Boston biotech firm Moderna, but will likely not be available to the public for another 18 months. The anti-viral drug remdesivir from Gilead has just recently been approved for public use now.

Barriers To Global Distribution

  • Individual countries can, and have, engaged in export bans and hoarding of medical stockpiles. With COVID, the U.S. and EU banned export of PPE and other medical supplies. During the H1N1 pandemic, a number of countries placed large orders for the vaccine before it became available, effectively leaving none for the rest of the world.
  • Intellectual property (IP) protections can make drugs inaccessible due to high prices. Patents bestow monopoly rights to the inventor to be the sole producer, distributer, and price-setter of a drug as a reward for the high costs of R&D. During a health crisis, if other producers can make the drug more cheaply then there’s a tension between honoring the IP and maximizing access.

Lessons From The AIDS Crisis

  • AIDS medication in the 1990s-2000s was wildly expensive because of IP enforcement. The 3-drug treatment for AIDS cost more than $10,000/person per year. Brazil and South Africa attempted to deny the patent rights and allow local, low-cost production of generic drugs. They faced lawsuits from 41 pharmaceutical companies.
  • The WTO had to step in to provide “compulsory licenses” enabling local companies to produce patented drugs without the owner’s consent.  The Trade-Related Aspects of Intellectual Property Rights (TRIPS) was amended to loosen IP protections during global public health emergencies. As a result, the cost of AIDS treatment came down to $100/person per year.

Incentivizing A Low-Cost Cure

  • Producers should be substantially rewarded for the invention of a cure to incentivize them to forgo their patent rights to production and distribution. Bringing a new drug to market costs more than $1 billion. A prize system could give them a substantial reward for the discovery, in exchange for other companies who produce and distribute at a much lower cost to be given the IP.
  • If drug-makers don’t give up their production and distribution rights then poorer countries may have to resort to WTO “compulsory licenses” as a last resort. The TRIPS mechanism acts as a global guarantee for poor countries to gain access. But there are drawbacks like potential safety issues if local producers don’t meet quality standards.

Ensuring Distribution Equity

  • Bring international organizations, governments, private companies, research institutions, and NGOs into cooperative relationships. One effort known as the Open COVID Pledge encourages companies and research institutions to make their IP temporarily available for free until a year after the WHO declares the pandemic to be over, at which point they can go back to owning commercial licenses for their intellectual property.
  • Governments will have to overcome steep challenges to ensure access. Even under normal conditions transport and supply chain issues, civil unrest, and natural disasters can undermine drug delivery. In the midst of a global crisis, the logistical hurdles will be even more daunting.

About The Author

Chetan Hebbale is currently a graduate student at the Johns Hopkins School of Advanced International Studies (SAIS) in Washington, D.C. focused on international economics, climate change, and sustainability.

Prior to this, he spent over 4 years at Deloitte Consulting working on technology and strategy projects at the CDC and U.S. Treasury Department.

He is a native of Atlanta, GA and attended the University of Georgia.

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Categories
Health Long Form

Incentivizing Kidney Donations: A Tax Credit Scheme

Introduction

There is an organ crisis in America. Currently, hundreds of thousands of Americans are on waiting lists to receive organ transplantations for livers, hearts, and kidneys and fewer and fewer organs are being donated every year. The most egregious of these shortages is being seen in the kidney market where an estimated 50,000 Americans will die waiting for a kidney this year alone.

This failure of supply to keep up with demand has its roots in a failure to provide incentives for individuals to donate their organs. It is currently illegal to sell ones kidney and receive monetary compensation. The current proposals around this involve tweaking current laws to acquire ones organs after death, or repealing the ban altogether and allowing for direct compensation.

There are several practical and moral flaws with both of these initiatives, thus this paper proposes a tax-credit scheme to incentivize individuals to give up their kidneys as an alternative. This tax-credit would not violate the ban currently in place to compensate those for donation and would avoid the flaws in previous proposals to give America a fighting chance to overcome this organ crisis.

Background

In 1984, the National Organ Transplant Act was passed in the United States which deemed it illegal for anyone to sell or acquire an organ for “valuable consideration”. The passage of this law set the precedent for any and all organ transplantations to occur only if the organ was received through donation; purchase or sale of organs resulted in five year prison sentence and a hefty fine (FindLaw).

Unfortunately, only 30-40% of Americans have listed themselves as organ donors on a driver’s license or through state run donor registries (Satel), and the gap between those on the waiting-list to receive organs and the amount of organs donated annually continues to widen (Organdonor.gov).

In 2006, 70,000 Americans were waiting for life-saving kidney transplantations and around 10,000 kidneys were donated that year (Satel). As of September 8th 2014, over 120,000 Americans are waiting for kidneys and around 16,000 kidneys have been donated (National Kidney Foundation). To this day, someone on the list waiting for a kidney dies about every 90 minutes (Satel) with a staggering rate of 50,000 individuals expected to die this year still waiting for a kidney (Beard, Kaserman and Osterkamp).  

If there is no structural change in either the system of organ procurement or the technology of transplant medicine, the likelihood of resolving current shortages in kidney donation looks very bleak. A simple simulation model based on current data around US renal waiting lists predicts that by 2015 the amount of Americans waiting for a kidney will balloon to over twice the amount in 2006 to 160,000 and lives lost to kidney shortages will exceed 100,000 (Beard, Kaserman and Osterkamp).

This problem is compounded by the current health crisis in America where the conditions that give rise to renal failure such as diabetes, high blood pressure and obesity are increasing exponentially (Beard, Kaserman and Osterkamp). America will see a greater demand for kidneys in future and the current rate of donation is already not meeting the demand, thus the impending organ crisis in this country has made one thing clear – relying on altruism is not enough.

Literature Review

The solution is obvious – increase the overall kidney supply pool in some way. There have been several methods discussed to increase the supply, but they have split along two camps: those that work within the National Organ Transplant Act and those that seek its repeal. Those that wish to work within NOTA have pushed two main initiatives – expanding organ donor eligibility to patients who have died of cardiac arrest (currently outlawed) and adopting the European practice of “presumed consent” whereby citizens are considered organ donors upon their death unless they have explicitly signed an anti-donor or opt-out card (Satel). However, the total amount of organs that would be added to the pool from implementing either of those strategies alone or together would fall far short of the booming demand (Abadie and Gay).

Those that wish to repeal NOTA have championed legislation that would remove the ban on the sale or purchase of organs and would allow direct cash compensation in exchange for kidneys, hearts, livers etc. Economists globally have supported this method with over 70 percent favoring the legalization of organ sales (Beard, Kaserman and Osterkamp). From their perspective, the shortage of organs is a result of a failure to provide incentives – there is really no incentive for someone to give up a non-vital organ such as a kidney before their death if their only motivation is the desire to help someone else.  Economists argue that by opening a free-market for organs both the demand and supply side of the equation would be helped. 

On the supply side, given that demand is so high for the organs there would be a huge incentive to sell one’s own organs or those of a deceased family member and collect a very good price. Economists argue that legalization could single-handedly eliminate the shortage for organs given that the average cost for a kidney transplantation is $259,000 and even a fraction of that as compensation would skyrocket supply (Becker and Elias). On the demand side organ exchange businesses would arise and begin selling organs at lower prices. As competition to buy organs increases given the increasing demand, companies would continue to slash prices to capture the market demand leading to overall lower prices for those in need of organs as well (Andiew and Block).

The push-pack to this proposal has been strong from many fronts, in particular the Institute of Medicine cautioning that this will lead to a slippery slope of treating the body as if it were “for sale”. Studies have shown that financial incentives may actually lead to a decline in the supply of organs because it distorts the signal about preferences that organ donation gives which is meant to be purely altruistic in nature and perhaps “cheapens” the process (Byrne and Thompson).  

Proponents of the legalization of organ sales argue that that form of thinking is outdated given that America has already accepted a free market approach for human eggs, sperm and surrogate mothers (Satel). However, there is legitimate concern that the legalization of organ sales could spur unethical and even criminal exploitation of vulnerable donors (Danovitch and Delmonico). Opponents argue that legalization will set off a global race of “transplant tourism” where organized crime rings would travel across impoverished areas in the United States and around the world to capture and harvest organs from powerless individuals and sell their organs on the market for a profit (Danovitch and Delmonico). This possibility has shown to be uniquely likely for kidneys. In Hong Kong and Israel where the sale of kidneys had been legalized, there was a sharp increase in unnamed or unidentified kidney sales (Danovitch and Delmonico).

Given these risks, this paper argues for a third option as an alternative to legalization and methods that still maintain NOTA – providing a weak economic incentive to donate organs. Thomas Søbirk from the University of Roskilde in Denmark has argued that individuals are more likely to donate to a particular cause the more of their donations they are able to deduct from their taxes. Extrapolating from this conclusion, a tax-credit mechanism to compensate individuals for organ donations may be able to satisfy the demand for kidneys. If individuals can only receive deductions in their taxes in that country that should theoretically eliminate the risk of foreign organ sellers who would not be able to collect the benefits of harvesting illegal organs, but still able to increase the supply of the overall organ and kidney pool.

Analysis

A tax-credit scheme as a solution to the current shortage in kidney donations, in particular the one I am proposing, will take form in two separate ways. The first is offering an annual tax credit (~$500) for an individual agreeing to be an organ donor upon their death. The second is receiving a tax credit for donating a kidney as a living donor. There are two components to this as well – the first is that there is a fixed rate of a $5,000 deduction in taxes per kidney donated. Humans cannot survive with less than one of their two kidneys so this will be a one-time deduction. The second component is where any costs incurred as a result of donating the kidney (the procedure, recovery, travel etc) will be deducted from their taxable income.

To prevent against abuse and exploitation of this system, I propose a $15,000 cap on deductions as well as all expenditures being cleared by a medical doctor as an expense derived from the removal of the kidney.  This tax-credit should theoretically increase the pool of kidney donations in two ways. First, it works to address the negative impacts of donating an organ by compensating individuals and secondly it attaches a positive incentive to donate with the promise of future deductions in their taxable income. If all individuals in this economy are seeking to maximize their utility, this measure ensures that individuals are not worse off after donating their kidney and are in fact better off in the future.

According to the Grossman Model, health is an investment that can accumulate or depreciate over time. The choice to donate an organ is detrimental to one’s health even if only in the short-term since there are costs associated with recovery. The equation below projects an individual’s lifetime utility. The individuals discount date, δ, is a measure of much they value utility now more than in the future. In this scenario, an individual choosing to give up a non-vital organ like a kidney in exchange for the reward of tax reduction (indirectly compensation) indicates that they value utility in the future more than they value utility now and thus have a large δ.

I now want to address potential concerns with this proposal as opposed to the ones discussed in the literature. The first concern is that the tax-credit will ultimately have no effect on increasing the rate of kidney donation and may actually decrease the number of people willing to donate. The idea that the tax-credit proposal would be counter-productive in increasing donation draws from the Byrne and Thompson paper that financial incentives distort the signal of organ donation and cheapen the process – this is formally known as the Titmuss objection.

Richard Titmuss established the framework of blood donation using payment as an incentive versus a system of altruistic unpaid donors (Buyx). In his work, he alleges that paying for giving up your blood changes the social meaning of giving blood because it denies those individuals the ability to gift those who are in need and makes them less likely to donate. The proposal may succumb to this criticism as a tax deduction in exchange for kidney donation would make the donation no longer a pure gift, thus depriving donors the ability to make a moral choice and theoretically making them less likely to donate.

While Titmuss bases his conclusions empirically, they may not apply to organ donation as they do to blood donation.  As mentioned earlier, studies have shown that individuals are more likely to donate to a particular cause the more of their donations they are able to deduct from their taxes, and in particular studies suggest that even a modest cash payment would increase the number of organ donors (Kittur and Hogan).

However, a tax-credit does not have to be compulsory and could avoid the Titmuss objection all together. Individuals can choose to donate their organs without receiving the tax deduction and could in fact give monetary value of the tax-break to a charity of their choice, thus retaining the donation as purely an altruistic act. Ultimately what is more important is preventing people from dying on waiting-lists for organs and if a tax-credit can help reduce these needless deaths we have a moral obligation to pursue it even if may rob some of the ability to perform an altruistic act. The kidney shortage has compounded into a crisis precisely because of the failure of altruism to provide the necessary impetus to donate organs.

The second objection is that this tax-credit scheme could lead to exploitation of the poor. Tax benefits are intuitively less appealing to the wealthy since they are already retaining a sufficient amount of their income to live comfortably, thus this policy will disproportionately affect those in lower income brackets trying to take advantage of the promise of lower taxes. This, however, is not really an argument against the efficacy of the tax-credit if it ultimately increases the number of kidneys donated to the pool. More importantly, the action of giving up ones kidney is a voluntary choice and as long as the poor can benefit from this proposal while also helping others in need it should not be considered exploitative.

The more important question is if this proposal is able to address concerns of transplant tourism as a form of exploitation of the poor. As mentioned before, one of the principle concerns of legalizing organ sales is the fear that individuals may forcibly remove organs from the poor domestically and internationally to sell both in legal and black markets. This proposal works against such insidious acts in two ways. First, in order to claim any tax deductions the organs must come from the claimant’s body itself which can be verified with simple medical scans. Secondly, if there is an influx of organs donated following the implementation of this tax-credit this would eliminate the value of illicitly obtained organs abroad or domestically because supply is already catching up to demand and registered, “legally obtained” organs would already be available.

The idea of legally obtained organs begs the question of the final concern – is a tax-credit for donating organs legal under the National Organ Transplant Act? I believe it is under certain legal interpretations.

First, NOTA explicitly prohibits donors from transferring human organs for “valuable consideration”, but the tax-credit does not give deductions based on the expense of the organ itself but on the expenses incurred in donating the organ. In other words, the donor is not being compensated for the value of their organ, but rather being compensated for the travel, lodging, lost wages, recovery costs etc associated with donating the organ.

Second, NOTA’s jurisdiction extends only as far as inter-state commerce is concerned, if states implement this policy at the local and state level in ways that would have no bearing on inter-state commerce then it should remain perfectly legal. Preventing the tax-credit from interfering with interstate commerce could occur in a few ways – recipients can only receive organs from donors within their state, donors can only receive a deduction in their state taxes not federal taxes etc.  Despite these work-around methods, more should be done to help those dying every day on kidney transplant waiting lists and political action to repeal NOTA maybe what is truly needed to make a substantial dent in organ shortages.

Conclusion

As is, supply will not catch up with demand in the organ transplant market and hundreds of thousands will die every year waiting to receive a kidney. Unfortunately this trend will only grow as more and more individuals are succumbing to the epidemic in diabetes, obesity etc which is leading to increased kidney failures. In order to change the market there needs to be a change in incentives.

This paper proposes a weak economic incentive, a tax-credit, to encourage individuals to donate their kidneys for those in need. This tax-credit works two-fold: a smaller tax-credit (~$500) every year for agreeing to be an organ donor upon their death and second larger tax-credit which compensates individuals for the costs incurred to donate their kidney. While this is certainly not the silver bullet needed to close the large gap for organ transplants, it will go a long way. Though many have reservations about this proposal, both from a legal and moral perspective, it is the most viable option compared to the alternatives.

Initiatives that work purely within the National Organ Transplant Act would not be able to contribute enough organs and primarily require waiting on individuals to pass on before acquiring their organs – this is time we do not have. Initiatives that ask to repeal NOTA and allow direct compensation for organ donation, although popular, risk “transplant tourism” where individuals may kidnap the poor and helpless and harvest their organs and sell on the market. In addition, full legalization and compensation faces the Titmuss objection that alleges compensation commodifies the social meaning of purely altruistic donation and will turn people against donation.

A tax-credit proposal avoids most of these concerns. Empirical research has shown that charitable donations increase if they are tied to reduction in taxes, and more so any form of compensation is an impetus to donate organs – this should allow tax-credits to increase organ donations in the short-term. Tax-credits are able to avoid the Titmuss objection because it retains the donation of ones organ as purely a gift and only compensates the individual for the costs they incur in bestowing the gift, not awarding them anything in addition for doing a good deed.

Tax credits are also able to avoid fears of transplant tourism by ensuring that those who receive the deduction can only provide organs from their own bodies and additionally the increase in supply in the market will reduce the inclination to accept organs from unidentified donors. Finally, this proposal is able to skirt questions of legality under NOTA. First, it is not directly compensating donors for the value of their organ but the cost undertaken by the donor to give up their organ, and secondly it can be implemented by the states as to avoid issues of inter-state commerce – where NOTA is able to enforce its jurisdiction.

Ultimately, someone is dying every hour and half from needing an organ transplant. By next year, over 100,000 individuals will die in the wealthiest country in the world waiting for a kidney. We have a moral obligation to prevent these needless deaths from occurring and a tax-credit scheme to incentivize individuals to donate their kidneys is a promising first step.


Works Cited

  • Abadie, Alberto and Gay, Sebastien. “The impact of presumed consent legislation on cadaveric organ donation: A cross-country study”,  Journal of Health Economics 25 (2006) 599–620
  • Andiew, Scott and Harold, Block. “Organ Transplant: Using the Free Market Solves the Problem”, Journal of Clinical Research in Bioethics, May 2011
  • Beard, Randolph, Kaserman, David & Osterkamp, Rigmar. “The Global Organ Shortage: Economic Causes, Human Consequences, Policy Responses. Stanford University Press, page 68-71 and 207-212 (appeared in a review in the Journal of Political Economy)
  • Becker, Gary S., and Julio Jorge Elías. 2007. “Introducing Incentives in the Market for Live and Cadaveric Organ Donations.” Journal of Economic Perspectives, 21(3): 3-24.
  • Buyx, Alena. “Blood Donation, Payment, and Non-Cash Incentives: Classical Questions Drawing Renewed Interest”, Transfus Med Hemother. Oct 2009; 36(5): 329–339
  • Byrne, Margaret and Thompson, Peter. “A positive analysis of financial incentives for cadaveric organ donation”, Journal of Health Economics. Jan2001, Vol. 20 Issue 1, p69-83. 15p.
  • Danovitch, Gabriel and Delmonico, Francis. “The prohibition of kidney sales and organ markets should remain”, Current Opinion in Organ Transplantation: August 2008 – Volume 13 – Issue 4 – p 386–394
  • FindLaw, “Can I Sell an Organ”, http://healthcare.findlaw.com/patient-rights/can-i-sell-an-organ.html
  • Kittur DS, Hogan MM, Thukral VK, et al “Incentives for organ donation?”, Lancet, 1991; 2:1441.1991;2:1441
  • Satel, Sally. “Death’s Waiting List”, http://www.nytimes.com/2006/05/15/opinion/15satel.html?_r=2&oref=slogin&
  • National Kidney Foundation. “ORGAN DONATION AND TRANSPLANTATION STATISTICS”, http://www.kidney.org/news/newsroom/factsheets/Organ-Donation-and-Transplantation-Stats
  • Organdonor.gov. “The Need Is Real: Data”, http://www.organdonor.gov/about/data.html

Categories
Health Technology

The Threat of Weaponized Botox

            Botulinum toxin is a neurotoxin produced by the bacteria Clostridium botulinum. The bacteria is an anaerobic (doesn’t require oxygen to grow), gram-positive (contains peptidoglycan in its cell wall), spore-forming rod found on plants, in soil, water and the intestinal tracts of animals. C. botulinum has eight antigencically distinguishable exotoxins (A, B, C1, C2, D, E, F, G) some of which have commercial and cosmetic application but others of which are considered to be the most dangerous poison on Earth. Botulinum toxin-A is popularly known as Botox and is used to reduce facial wrinkles and aging effects, but its closest neighbor Botulinum toxin-B can be harnessed to create pathogenic disease outbreaks across populations.

            All serotypes of botulinum are single polypeptide chains with a molecular mass of about 150 kDa and a high degree of amino acid sequence homology. The polypeptide chain contains and heavy (H) and light (L) chain which play a crucial role in its pathogenesis[1]. Botulinum’s toxicity is orchestrated through its interference in neural transmission by blocking the release of acetylcholine at four different sites in the body:  the neuromuscular junction, autonomic ganglia, postganglionic parasympathetic nerve endings and postganglionic sympathetic nerve endings[2]. Acetylcholine is the principle neurotransmitter in neuromuscular junctions which makes its inhibition result primarily in muscle paralysis .The heavy (H) chain binds irreversibly to the high affinity receptors on neurons allowing the toxin-receptor complex to enter the cell via endocytosis which then allows the light (L) chain to interact with various surface proteins to prevent fusion of acetylcholine vesicles with the cell membrane[3].. The initial symptoms begin with acute weakness of muscles causing difficulty in speaking, swallowing and blurred vision. This followed by flaccid paralysis beginning at the muscles in the head and throat and can eventually cause death from respiratory muscle paralysis[4].

            Because of the speed and potency with which Botulinum strikes the body, it is considered one of the most toxic poisons known to humans. It’s estimated that even a single gram of pure crystalline toxin evenly dispersed and inhaled could kill as many as one million people[5]. The estimated lethal dose for a 200 pound person is around 0.9 – 1.2 micrograms by inhalation and approximately 90 micrograms by oral ingestion with symptoms appearing as quickly as 2 hours to as late as 8 days. In its solid form it is a white crystalline solid and in its liquid form it is colorless and odorless. Because the toxin is a protein, it is sensitive to heat and denatured at temperatures above 80 C (176 F) after 10 minutes[6].

            Because of its extremely high toxicity (100 times more toxic than sodium cyanide), Botulinum toxin has been at the top of bioweapon candidate agents. C. botulinum is easy to grow in large quantities and able to be stored at incubation without much technical sophistication. Weaponizing botulinum would be a complex, multi-stage process where in the final stage the toxin would have to bind to a finely powdered material like bentonite or silica gel[7]. This binding allows the bacteria to form a stable aerosol vehicle for dissemination.

            Terrorists have already attempted to use botulinum as a bioweapon. On at least 3 occasions between 1990 and 1995, the Japanese cult Aum Shinrikyo used aerosols to disperse the bacterial agent in Tokyo and on US military installations, but these attempts failed due to deficient aerosol-generating equipment and no one was killed[8]. The group acquired their C. botulinum from soil that they had collected in northern Japan. While non-state actors like Aum Shinrikyo have been unsuccessful, state actors have long been developing botulinum toxin as a bioweapon. In the 1930s, Japan’s government developed Unit 731, a bioweapons research complex, to test the effect botuliun had on Chinese, Korea and American prisoners it captured in the 1930s. The United States produced botulinum toxin during World War II out of fear that Germany had done so already (which they had). In fact before the D-Day invasion, over a million doses of botulinum toxoid vaccine were administered to Allied troops[9]. Even though Iraq and the Soviet Union were signatories to the 1972 Biological and Toxic Weapons Convention, both produced it for use as a weapon. Former senior scientists of the Russian civilian bioweapons program admit that botulinum toxin was tested at the Soviet site Aralsk-7 on Vozrozhdeniye Island in the Aral Sea[10]. After the demise of the Soviet Union, thousands of scientists employed by its bioweapons program have been recruited by nations attempting to develop biological weapons, specifically botulinum toxin, including Iran, North Korea and Syria[11]. After the Gulf War in 1991, Iraq admitted to having produced 19,000 liters of concentrated botulinum toxin with about 10,000 liters loaded into military weapons. The 19,000 liters to this day are not entirely accounted for and constitute more than three times the amount needed to kill the entire human population by inhalation. Amongst the range of biological weapons that Saddam’s Iraq had developed it chose to weaponize more botulinum toxin than any other agent. [12]

            Analysts now downplay the potential for botulinum to be used as a bioweapon because of constraints in concentrating and stabilizing the toxin for aerosol dissemination[13]. The flaw in these analyses, however, is that they pertain only to military use in immobilizing an opponent rather than release of the agent in a civilian population. It’s estimated that a point-source release could incapacitate or kill 10% of persons downwind from the initial release which could wreak havoc in a populated civilian setting such as a subway transit or sports arena[14]. More dangerous than aerosol dispersion though would be the          use of the toxin through the contamination of food which could result in widespread epidemics. Terrorists generally consider these “soft” targets, since they are almost impossible to guard at all times. Contamination of the food supply could come through spraying the agent on fruits and vegetables or through processed foods like dairy products or through hamburger and canned meats.

            In order to recognize a biological attack from botulinum, there would have had to have been an outbreak with a significant number of incidents of flaccid paralysis all stemming from one geographic location. Once recognized, treating those affected and containing the spread can be very difficult. For some symptoms of botulinum infection do not appear for 8 days meaning they could inadvertently spread the toxin amongst family, co-workers etc before showing any signs[15]. Once an individual begins to show signs treatment would include breathing assistance and possible intubation, botulinum anti-toxins and a toxoid vaccine[16] which may or not be successful depending on the severity of the infection on the body.  

Given that much of Iraq’s arsenal of weaponized botulinum toxin has been unaccounted for and thousands of bioweapons trained scientists from the Soviet Union have spread out across the globe, it is not hard to imagine that terrorist networks and perhaps even state actors have acquired strains of weaponized botulinum. While the current struggle may still be with efficient aerosol dispersal deign, there are more vulnerable targets today than there have been in the past.  Terrorists could easily target today’s vast supply chain of globalized food export where areas of the marketplace are unregulated and where a number of middlemen control the shipping process. With these risks, the United States ought to have emergency response and hospitals equipped with all the proper medications to be able to swiftly and efficiently deal with an outbreak of botulinum toxin.


[1] Arnon et al, “Botulinum Toxin as a Biological Weapon – Medical and Public Health Management”,  2001, http://www.bt.cdc.gov/agent/botulism/botulismconsensus.pdf

[2] Nigam, PK and Nigam, Anjana, “BOTULINUM TOXIN”, Indian J Dermatol. 2010 Jan-Mar; 55(1): 8–14.

[3] Hanson, Doug Phd. “Botulinum Toxin: A Bioterrorism Weapon”,  April 1st, 2004, http://www.emsworld.com/article/10324792/botulinum-toxin-a-bioterrorism-weapon

[4] Arnon et al, “Botulinum Toxin as a Biological Weapon – Medical and Public Health Management”,  2001, http://www.bt.cdc.gov/agent/botulism/botulismconsensus.pdf

[5] Nigam, PK and Nigam, Anjana, “BOTULINUM TOXIN”, Indian J Dermatol. 2010 Jan-Mar; 55(1): 8–14.

[6] Nigam, PK and Nigam, Anjana, “BOTULINUM TOXIN”, Indian J Dermatol. 2010 Jan-Mar; 55(1): 8–14.

[7] Arnon et al, “Botulinum Toxin as a Biological Weapon – Medical and Public Health Management”,  2001, http://www.bt.cdc.gov/agent/botulism/botulismconsensus.pdf

[8] Arnon et al, “Botulinum Toxin as a Biological Weapon – Medical and Public Health Management”,  2001, http://www.bt.cdc.gov/agent/botulism/botulismconsensus.pdf

[9] Arnon et al, “Botulinum Toxin as a Biological Weapon – Medical and Public Health Management”,  2001, http://www.bt.cdc.gov/agent/botulism/botulismconsensus.pdf

[10] Nigam, PK and Nigam, Anjana, “BOTULINUM TOXIN”, Indian J Dermatol. 2010 Jan-Mar; 55(1): 8–14.

[11] Nigam, PK and Nigam, Anjana, “BOTULINUM TOXIN”, Indian J Dermatol. 2010 Jan-Mar; 55(1): 8–14.

[12]Arnon et al, “Botulinum Toxin as a Biological Weapon – Medical and Public Health Management”,  2001, http://www.bt.cdc.gov/agent/botulism/botulismconsensus.pdf

[13] Nigam, PK and Nigam, Anjana, “BOTULINUM TOXIN”, Indian J Dermatol. 2010 Jan-Mar; 55(1): 8–14.

[14] Hanson, Doug Phd. “Botulinum Toxin: A Bioterrorism Weapon”,  April 1st, 2004, http://www.emsworld.com/article/10324792/botulinum-toxin-a-bioterrorism-weapon

[15] Hanson, Doug Phd. “Botulinum Toxin: A Bioterrorism Weapon”,  April 1st, 2004, http://www.emsworld.com/article/10324792/botulinum-toxin-a-bioterrorism-weapon

[16] Hanson, Doug Phd. “Botulinum Toxin: A Bioterrorism Weapon”,  April 1st, 2004, http://www.emsworld.com/article/10324792/botulinum-toxin-a-bioterrorism-weapon