How thousands of first- and second-graders saved the world from a deadly disease
Exactly 67 years ago, in 1955, a group of scientists and reporters gathered at the University of Michigan and waited with bated breath for Dr. Thomas Francis Jr., director of the school’s Poliomyelitis Vaccine Evaluation Center, to approach the podium. The group had gathered to hear the news that seemingly everyone in the country had been anticipating for the past two years – whether the vaccine for poliomyelitis, developed by Francis’s former student Jonas Salk, was effective in preventing the disease.
Polio, at that point, had become a household name. As the highly contagious virus swept through the United States, cities closed their schools, movie theaters, swimming pools, and even churches to stop the spread. For most, polio presented as a mild illness, and was usually completely asymptomatic – but for an unlucky few, the virus took hold of the central nervous system and caused permanent paralysis of muscles in the legs, arms, and even people’s diaphragms, rendering the person unable to walk and breathe. It wasn’t uncommon to hear reports of people – mostly children – who fell sick with a flu-like virus and then, just days later, were relegated to spend the rest of their lives in an iron lung.
For two years, researchers had been testing a vaccine that would hopefully be able to stop the spread of the virus and prevent the 45,000 infections each year that were keeping the nation in a chokehold. At the podium, Francis greeted the crowd and then proceeded to change the course of human history: The vaccine, he reported, was “safe, effective, and potent.” Widespread vaccination could begin in just a few weeks. The nightmare was over.
The road to success
Jonas Salk, a medical researcher and virologist who developed the vaccine with his own research team, would rightfully go down in history as the man who eradicated polio. (Today, wild poliovirus circulates in just two countries, Afghanistan and Pakistan – with only 140 cases reported in 2020.) But many people today forget that the widespread vaccination campaign that effectively ended wild polio across the globe would have never been possible without the human clinical trials that preceded it.
As with the COVID-19 vaccine, skepticism and misinformation around the polio vaccine abounded. But even more pervasive than the skepticism was fear. The consequences of polio had arguably never been more visible.
The road to human clinical trials – and the resulting vaccine – was a long one. In 1938, President Franklin Delano Roosevelt launched the National Foundation for Infantile Paralysis in order to raise funding for research and development of a polio vaccine. (Today, we know this organization as the March of Dimes.) A polio survivor himself, Roosevelt elevated awareness and prevention into the national spotlight, even more so than it had been previously. Raising funds for a safe and effective polio vaccine became a cornerstone of his presidency – and the funds raked in by his foundation went primarily to Salk to fund his research.
The Trials Begin
Salk’s vaccine, which included an inactivated (killed) polio virus, was promising – but now the researchers needed test subjects to make global vaccination a possibility. Because the aim of the vaccine was to prevent paralytic polio, researchers decided that they had to test the vaccine in the population that was most vulnerable to paralysis – young children. And, because the rate of paralysis was so low even among children, the team required many children to collect enough data. Francis, who led the trial to evaluate Salk’s vaccine, began the process of recruiting more than one million school-aged children between the ages of six and nine in 272 counties that had the highest incidence of the disease. The participants were nicknamed the “Polio Pioneers.”
Double-blind, placebo-based trials were considered the “gold standard” of epidemiological research back in Francis's day - and they remain the best approach we have today. These rigorous scientific studies are designed with two participant groups in mind. One group, called the test group, receives the experimental treatment (such as a vaccine); the other group, called the control, receives an inactive treatment known as a placebo. The researchers then compare the effects of the active treatment against the effects of the placebo, and every researcher is “blinded” as to which participants receive what treatment. That way, the results aren’t tainted by any possible biases.
But the study was controversial in that only some of the individual field trials at the county and state levels had a placebo group. Researchers described this as a “calculated risk,” meaning that while there were risks involved in giving the vaccine to a large number of children, the bigger risk was the potential paralysis or death that could come with being infected by polio. In all, just 200,000 children across the US received a placebo treatment, while an additional 725,000 children acted as observational controls – in other words, researchers monitored them for signs of infection, but did not give them any treatment.
As with the COVID-19 vaccine, skepticism and misinformation around the polio vaccine abounded. But even more pervasive than the skepticism was fear. President Roosevelt, who had made many public and televised appearances in a wheelchair, served as a perpetual reminder of the consequences of polio, as an infection at age 39 had rendered him permanently unable to walk. The consequences of polio had arguably never been more visible, and parents signed up their children in droves to participate in the study and offer them protection.
The Polio Pioneer Legacy
In a little less than a year, roughly half a million children received a dose of Salk’s polio vaccine. While plenty of children were hesitant to get the shot, many former participants still remember the fear surrounding the disease. One former participant, a Polio Pioneer named Debbie LaCrosse, writes of her experience: “There was no discussion, no listing of pros and cons. No amount of concern over possible side effects or other unknowns associated with a new vaccine could compare to the terrifying threat of polio.” For their participation, each kid received a certificate – and sometimes a pin – with the words “Polio Pioneer” emblazoned across the front.
When Francis announced the results of the trial on April 12, 1955, people did more than just breathe a sigh of relief – they openly celebrated, ringing church bells and flooding into the streets to embrace. Salk, who had become the face of the vaccine at that point, was instantly hailed as a national hero – and teachers around the country had their students to write him ‘thank you’ notes for his years of diligent work.
But while Salk went on to win national acclaim – even accepting the Presidential Medal of Freedom for his work on the polio vaccine in 1977 – his success was due in no small part to the children (and their parents) who took a risk in order to advance medical science. And that risk paid off: By the early 1960s, the yearly cases of polio in the United States had gone down to just 910. Where before the vaccine polio had caused around 15,000 cases of paralysis each year, only ten cases of paralysis were recorded in the entire country throughout the 1970s. And in 1979, the virus that once shuttered entire towns was declared officially eradicated in this country. Thanks to the efforts of these brave pioneers, the nation – along with the majority of the world – remains free of polio even today.
“Disinfection Tunnels” Are Popping Up Around the World, Fueled By Misinformation and Fear
In an incident that sparked widespread outrage across India in late March, officials in the north Indian state of Uttar Pradesh sprayed hundreds of migrant workers, including women and children, with a chemical solution to sanitize them, in a misguided attempt to contain the spread of the novel coronavirus.
Since COVID-19 is a respiratory disorder, disinfecting a person's body or clothes cannot protect them from contracting the novel coronavirus, or help in containing the pathogen's spread.
Health officials reportedly doused the group with a diluted mixture of sodium hypochlorite – a bleaching agent harmful to humans, which led to complaints of skin rashes and eye irritation. The opposition termed the instance 'inhuman', compelling the state government to order an investigation into the mass 'chemical bath.'
"I don't think the officials thought this through," says Thomas Abraham, a professor with The University of Hong Kong, and a former consultant for the World Health Organisation (WHO) on risk communication. "Spraying people with bleach can prove to be harmful, and there is no guideline … that recommends it. This was some sort of a kneejerk reaction."
Although spraying individuals with chemicals led to a furor in the South Asian nation owing to its potential dangers, so-called "disinfection tunnels" have sprung up in crowded public places around the world, including malls, offices, airports, railway stations and markets. Touted as mass disinfectants, these tunnels spray individuals with chemical disinfectant liquids, mists or fumes through nozzles for a few seconds, purportedly to sanitize them -- though experts strongly condemn their use. The tunnels have appeared in at least 16 countries: India, Malaysia, Scotland, Albania, Argentina, Colombia, Singapore, China, Pakistan, France, Vietnam, Bosnia and Herzegovina, Chile, Mexico, Sri Lanka and Indonesia. Russian President Vladimir Putin even reportedly has his own tunnel at his residence.
While U.S. visitors to Mexico are "disinfected" through these sanitizing tunnels, there is no evidence that the mechanism is currently in use within the United States. However, the situation could rapidly change with international innovators like RD Pack, an Israeli start-up, pushing for their deployment. Many American and multinational companies like Stretch Structures, Guilio Barbieri and Inflatable Design Works are also producing these systems. As countries gradually ease lockdown restrictions, their demand is on the rise -- despite a stringent warning from the WHO against their potential health hazards.
"Spraying individuals with disinfectants (such as in a tunnel, cabinet, or chamber) is not recommended under any circumstances," the WHO warned in a report on May 15. "This could be physically and psychologically harmful and would not reduce an infected person's ability to spread the virus through droplets or contact. Moreover, spraying individuals with chlorine and other toxic chemicals could result in eye and skin irritation, bronchospasm due to inhalation, and gastrointestinal effects such as nausea and vomiting."
Disinfection tunnels largely spray a diluted mixture of sodium hypochlorite, a chlorine compound commonly known as bleach, often used to disinfect inanimate surfaces. Known for its hazardous properties, the WHO, in a separate advisory on COVID-19, warns that spraying bleach or any other disinfectant on individuals can prove to be poisonous if ingested, and that such substances should be used only to disinfect surfaces.
Considering the effect of sodium hypochlorite on mucous membranes, the European Centre for Disease Prevention and Control, an EU agency focussed on infectious diseases, recommends limited use of the chemical compound even when disinfecting surfaces – only 0.05 percent for cleaning surfaces, and 0.1 percent for toilets and bathroom sinks. The Indian health ministry also cautioned against spraying sodium hypochlorite recently, stating that its inhalation can lead to irritation of mucous membranes of the nose, throat, and respiratory tract.
In addition to the health hazards that such sterilizing systems pose, they have little utility, argues Indian virologist T. Jacob John. Since COVID-19 is a respiratory disorder, disinfecting a person's body or clothes cannot protect them from contracting the novel coronavirus, or help in containing the pathogen's spread.
"It's a respiratory infection, which means that you have the virus in your respiratory tract, and of course, that shows in your throat, therefore saliva, etc.," says John. "The virus does not survive outside the body for a long time, unless it is in freezing temperatures. Disinfecting a person's clothes or their body makes no sense."
Disinfection tunnels have limited, if any, impact on the main modes of coronavirus transmission, adds Craig Janes, director, School of Public Health and Health Systems at Canada's University of Waterloo. He explains that the nature of COVID-19 transmission is primarily from person-to-person, either directly, or via an object that is shared between two individuals. Measures like physical distancing and handwashing take care of these transmission risks.
"My view of these kinds of actions are that they are principally symbolic, indicating to a concerned population that 'something is being done,' to martial support for government or health system efforts," says Janes. "So perhaps a psychological benefit, but I'm not sure that this benefit would outweigh the risks."
"They may make people feel that their risk of infection has been reduced, and also that they do not have to worry about infecting others."
A recent report by Health Care Without Harm (HCWH), an international not-for-profit organization focused on sustainable health care around the world, states that disinfection tunnels have little evidence to demonstrate their efficacy or safety.
"If the goal is to reduce the spread of the virus by decontaminating the exterior clothing, shoes, and skin of the general public, there is no evidence that clothes are an important vector for transmission. If the goal is to attack the virus in the airways, what is the evidence that a 20-30 second external application is efficacious and safe?" the report questions. "The World Health Organization recommends more direct and effective ways to address hand hygiene, with interventions known to be effective."
If an infected person walks through a disinfection tunnel, he would still be infectious, as the chemicals will only disinfect the surfaces, says Gerald Keusch, a professor of medicine and international health at Boston University's Schools of Medicine and Public Health.
"While we know that viruses can be "disinfected" from surfaces and hands, disinfectants can be harmful to health if ingested or inhaled. The underlying principle of medicine is to do no harm, and we always measure benefit against risk when approving interventions. I don't know if this has been followed and assessed with respect to these devices," says Keusch. "It's a really bad idea."
Experts warn that such tunnels may also create a false sense of security, discouraging people from adopting best practice methods like handwashing, social distancing, avoiding crowded places, and using masks to combat the spread of COVID-19.
"They may make people feel that their risk of infection has been reduced, and also that they do not have to worry about infecting others," says Janes. "These are false assumptions, and may lead to increasing rather than reducing transmission."
It looks like an ordinary toilet but it is anything but. The "smart toilet" is the diagnostic tool of the future, equipped with cameras that take snapshots of the users and their waste, motion sensors to analyze what's inside the urine and stool samples, and software that automatically sends data to a secure, cloud-based system that can be easily accessed by your family doctor.
"It's a way of doing community surveillance. If there is a second wave of infections in the future, we'll know right away."
Using urine "dipstick tests" similar to the home pregnancy strips, the smart toilet can detect certain proteins, immune system biomarkers and blood cells that indicate the presence of such diseases as infections, bladder cancer, and kidney failure.
The rationale behind this invention is that some of the best ways of detecting what's going on in our bodies is by analyzing the substances we excrete every day, our sweat, urine, saliva and yes, our feces. Instead of getting sporadic snapshots from doctor's visits once or twice a year, the smart toilet provides continuous monitoring of our health 24/7, so we can catch the tell-tale molecular signature of illnesses at their earliest and most treatable stages. A brainchild of Stanford University researchers, they're now working to add a COVID-19 detection component to their suite of technologies—corona virus particles can be spotted in stool samples—and hope to have the system available within the year.
"We can connect the toilet system to cell phones so we'll know the results within 30 minutes," says Seung-min Park, a lead investigator on the research team that devised this technology and a senior research scientist at the Stanford University School of Medicine. "The beauty of this technology is that it can continuously monitor even after this pandemic is over. It's a way of doing community surveillance. If there is a second wave of infections in the future, we'll know right away."
Experts believe that the COVID-19 pandemic will accelerate the widespread acceptance of in-home diagnostic tools such as this. "Shock events" like pandemics can be catalysts for sweeping changes in society, history shows us. The Black Death marked the end of feudalism and ushered in the Renaissance while the aftershocks of the Great Depression and two world wars in the 20th century led to the social safety net of the New Deal and NATO and the European Union. COVID-19 could fundamentally alter the way we deliver healthcare, abandoning the outdated 20th century brick and mortar fee-for-service model in favor of digital medicine. At-home diagnostics may be the leading edge of this seismic shift and the pandemic could accelerate the product innovations that allow for home-based medical screening.
"That's the silver lining to this devastation," says Dr. Leslie Saxon, executive director of the USC Center for Body Computing at the Keck School of Medicine in Los Angeles. As an interventional cardiologist, Saxon has spent her career devising and refining the implantable and wearable wireless devices that are used to treat and diagnose heart conditions and prevent sudden death. "This will open up innovation—research has been stymied by a lack of imagination and marriage to an antiquated model," she adds. "There are already signs this is happening—relaxing state laws about licensure, allowing physicians to deliver health care in non-traditional ways. That's a real sea change and will completely democratize medical information and diagnostic testing."
Ironically, diagnostics have long been a step-child of modern medicine, even though accurate and timely diagnostics play a crucial role in disease prevention, detection and management. "The delivery of health care has proceeded for decades with a blind spot: diagnostic errors—inaccurate or delayed diagnoses—persist throughout all settings of care and continue to harm an unacceptable number of patients," according to a 2015 National Academy of Medicine report. That same report found as many as one out of five adverse events in the hospital result from these errors and they contribute to 10 percent of all patient deaths.
The pandemic should alter the diagnostic landscape. We already have a wealth of wearable and implantable devices, like glucose sensors to monitor blood sugar levels for diabetics, Apple's smart watch, electrocardiogram devices that can detect heart arrythmias, and heart pacemakers.
The Food and Drug Administration is working closely with in-home test developers to make accurate COVID-19 diagnostic tools readily available and has so far greenlighted three at-home collection test kits. Two, LabCorp's and Everlywell's, use nasal swabs to take samples. The third one is a spit test, using saliva samples, that was devised by a Rutgers University laboratory in partnership with Spectrum Solutions and Accurate Diagnostic Labs.
The only way to safely reopen is through large scale testing, but hospitals and doctors' offices are no longer the safest places.
In fact, DIY diagnostic company Everlywell, an Austin, Texas- based digital health company, already offers more than 30 at-home kits for everything from fertility to food sensitivity tests. Typically, consumers collect a saliva or finger-prick blood sample, dispatch it in a pre-paid shipping envelope to a laboratory, and a physician will review the results and send a report to consumers' smartphones.
Thanks to advances in technology, samples taken at home can now be preserved long enough to arrive intact at diagnostic laboratories. The key is showing the agency "transport and shipping don't change or interfere with the integrity of the samples," says Dr. Frank Ong, Everlywell's chief medical and scientific officer.
Ong is keenly aware of the importance of saturation testing because of the lessons learned by colleagues fighting the SARS pandemic in his family's native Taiwan in 2003. "In the beginning, doctors didn't know what they were dealing with and didn't protect themselves adequately," he says. "But over two years, they learned the hard way that there needs to be enough testing, contact tracing of those who have been exposed, and isolation of people who test positive. The value of at-home testing is that it can be done on the kind of broad basis that needs to happen for our country to get back to work."
Because of the pandemic, new policies have removed some of the barriers that impeded the widespread adoption of home-based diagnostics and telemedicine. Physicians can now practice across state lines, get reimbursed for telemedicine visits and use FaceTime to communicate with their patients, which had long been considered taboo because of privacy issues. Doctors and patients are becoming more comfortable and realizing the convenience and benefits of being able to do these things virtually.
Added to this, the only way to safely reopen for business without triggering a second and perhaps even more deadly wave of sickness is through large-scale testing, but hospitals and doctors' offices are no longer the safest places. "We don't want people sitting in a waiting room who later find out they're positive, and potentially infected everyone, including doctors and nurses," says Dr. Kavita Patel, a physician in Washington, DC who served as a policy director in the Obama White House.
In-home testing avoids the risks of direct exposure to the virus for both patients and health care professionals, who can dispense with cumbersome protective gear to take samples, and also enables people without reliable transportation or child-care to learn their status. "At home testing can be a critical component of our country's overall testing strategy," says Dr. Shantanu Nundy, chief medical officer at Accolade Health and on the faculty of the Milken Institute School of Public Health at George Washington University. "Once we're back at work, we need to be much more targeted, and have much more access to data and controlling those outbreaks as tightly as possible. The best way to do that is by leapfrogging clinics and being able to deliver tests at home for people who are disenfranchised by the current system."
In the not-too-distant future, in-home diagnostics could be a key component of precision medicine, which is customized care tailored specifically to each patient's individual needs. Like Stanford's smart toilet prototype, these ongoing surveillance tools will gather health data, ranging from exposures to toxins and pollutions in the environment to biochemical activity, like rising blood pressure, signs of inflammation, failing kidneys or tiny cancerous tumors, and provide continuous real-time information.
"These can be deeply personalized and enabled by smart phones, sensors and artificial intelligence," says USC's Leslie Saxon. "We'll be seeing the floodgates opening to patients accessing medical services through the same devices that they access other things, and leveraging these tools for our health and to fine tune disease management in a model of care that is digitally enabled."
[Editor's Note: This article was originally published on June 8th, 2020 as part of a standalone magazine called GOOD10: The Pandemic Issue. Produced as a partnership among LeapsMag, The Aspen Institute, and GOOD, the magazine is available for free online.]