The Cutter Incident
– Neal Nathanson and Alexander D. Langmuir, The Cutter Incident, 1963.
Poliomyelitis may have always been a rare, perhaps accidental, complication of an otherwise undetected fecal-oral enterovirus infection. Most people don’t realize this, but according to the CDC, less than 1% of poliovirus infections result in any form of paralysis, and 72% of infections are completely asymptomatic.
The rare obscure cases of poliomyelitis (once called infantile paralysis and Heine Medin disease) that peppered the medical journals of the 1800s, transformed significantly after 1900 into epidemics that surged even higher in the 1940s and 1950s. By mid-century, the new phenomenon of epidemic poliomyelitis was affecting tens of thousands of school-aged children in highly modern countries from the US to the United Kingdom, Sweden and Australia–and looking for possible causes became a point of controversy, rather than good public health.
When doctors noticed that tonsillectomies and intramuscular injections such as DPT vaccination or penicillin were associated with an increased rate of poliomyelitis, either of the bulbar form or of the injected limb, as in the latter case, public health policies didn’t adapt to the new information, rather, DDT was sprayed in high amounts as a ‘polio prevention’ and the race for a polio vaccine was on.
If I had to guess, I would describe that most people share a cultural memory of the polio vaccine story as an unequivocally positive, perhaps epic moment in modern science: a ‘life saving vaccine’ was invented and ‘eradicated a crippling and deadly disease’–however there is a much more complex, nuanced historically accurate picture that includes unthinkable errors, catastrophic oversights, and fear-based assumptions.
While I find myself getting lost in all the details from cancer causing SV-40 virus to the global acute flaccid paralysis problem (in 2021, there were 86,920 cases of acute flaccid paralysis (AFP) which is technically poliomyelitis) to the hepatitis c epidemic among baby boomers to the connection between tonsillectomies and deadliest forms of paralytic polio, this article will focus on one event in history:
The Cutter Incident
The Race for a Vaccine
I found it interesting upon learning that the very first epidemic of polio in the US was said to be in 1894 in Otter Creek, Vermont, an outbreak that included horses, dogs, and fowls, which excludes poliovirus as the possible cause. You see, poliovirus only infects humans.
Since 1910, scientists like Simon Flexner at the Rockefeller Institute in New York City were actively studying poliovirus, just one year after the disease first became reportable. Flexner took spinal cord and fluid from infected poliomyelitis victims and injected the material into the brains of monkeys, in a desperate effort to cause infection, and recreate the rare form of anterior horn injury. All efforts had been unsuccessful to infect monkeys by feeding orally. It would turn out that humans are the only natural host for the enterovirus that was being associated with the terrible disease. The virus was named after the disease, which preceded it.
The term poliomyelitis in Greek means:
polio = gray
myelo = marrow
itis = inflammation
There are many diseases that involve injury to the gray matter of the spinal cord. Prior to the vaccine, most of these may have been attributed to poliomyelitis: Guillain-Barré syndrome, acute flaccid paralysis, acute flaccid myelitis, aseptic meningitis, myasthenia gravis, anterior horn disease, botulism, mercury poisoning.
Additionally, many viruses can cause poliomyelitis: coxsackie virus, echovirus, epstein barr virus, and other enteroviruses including enterovirus D68.
Flexner studied the virus’ neurotropism by selectively injecting the virus into the central nervous system of monkeys. They ended up creating their own strain of polio called the MV strain, which was a particularly neurotropic form.
Interestingly, this all happened just a few subway stops away from what would become known as the worst polio epidemic in US history: the 1916 polio epidemic which began in Brooklyn, New York. That epidemic had an unusually high death rate for any ‘polio epidemic’ before or since.
After 1916, cases of paralytic and non-paralytic polio began to climb. In 1925 there were 5,926 cases, and by 1949, just after the introduction of the DPT vaccine, there were 42,033 cases.
Dr. Jonas Salk and the IPV Vaccine
Virologist Dr. Jonas Salk had spent years developing the polio vaccine. He innovated a way to grow large amounts of polio virus in a short amount of time, which had previously only been successfully grown in polio-adapted monkeys, and then human embryo tissue.
Because it was difficult to secure large quantities of human embryo tissue for culture, and inducing polio in monkeys and removing only small amounts of virus from crushed up spinal cord is both time consuming and costly (it would take millions of monkeys to obtain the amount of virus needed), Salk chose a monkey’s kidney to use as a tissue culture.
Mrs. Annabelle Nelson, age 33, of Montpelier, Idaho, died on June 5 of bulbar polio after her two children had been inoculated with Salk vaccine manufactured by Cutter laboratories.
Perfecting his technique, the medical doctor went through at least 50 rhesus macaques each week. He and his lab assistants would anesthetize the monkeys, kill them with ether, cut out their bean shaped kidneys, an organ known most for removing waste from the body, then ground up the kidneys with scissors or a blender, and combined this mixture with a nutrient broth and spinal fluid from a polio victim containing polio virus.
Flasks filled with fluid were placed in warm incubating rooms, and in this mixture the virus would replicate over and over, producing enough for vaccines.
But first, Salk needed to ‘inactivate’ or ‘kill’ the lethal virus by soaking the mixture in formalin (a formaldehyde solution) for several weeks. The results would be known as the inactivated polio vaccine (IPV), which the doctor would be widely recognized for, and receive much acclaim.
Many scientists at the time had reservations about the process of inactivation, such as Albert Sabin, who was also in the race for a vaccine, developing his own polio vaccine: the ‘live’ attenuated oral polio vaccine (OPV).
The process of ‘attenuation’, which involved passaging the virus through monkeys to get the virus weaker, appeared safer to many people at the time. We all know that when a virus circulates through the population, it generally gets weaker and less virulent.
But Jonas Salk wasn’t deterred from his mission. He took his vaccine to D.T. Watson Home for Crippled Children and tested the ‘inactivated’ vaccine on 30 children who had already survived polio using just one glass syringe for all children, simply because disposable syringes had not been invented yet. No side effects were reported or published.
1954 Field Trial
Then in 1954, a much larger field trial was planned using Salk’s inactivated vaccine design, created by two manufacturers who were able to successfully create large quantities of vaccine: Parke-Davis and Eli Lilly. But before the trial began, some batches of vaccines were found to contain live poliovirus, but because the field trial had many safety checks in place through the NIH, those batches were not released to the children participating in the field trial.
But it did signal that manufacturers were not able to follow Salk’s protocol efficiently, and were struggling with inactivating the virus, which would bode a haunting premonition for the future.
The cherry red colored vaccine (see image above) was tested on 200,000 children in different parts of the US, and outcomes were compared to 200,000 children who received also a cherry red colored placebo (the placebo that was used was culture fluid without poliomyelitis virus or monkey kidney protein) and 338,000 children who received no injection at all. So technically, there were two different control groups.
After many months of analysis, the results were in: the children who got the “placebo” injection of culture fluid had a higher rate of poliomyelitis (0.05%) than the “vaccine” group (0.01%) AND the completely un-injected control group (0.03%).
Salk made the announcement April 12, 1955 that the vaccine was found ‘safe, effective, and potent.’
Read the Field Trial Here: 1954FieldTrial
Did you know that some indigenous cultures were studied in the 1960s like the Brazilian Xavante tribe, who were found to have antibodies to all 3 strains of poliovirus, and no cases of paralytic polio at all? In a healthy ecosystem, it may be a harmless microbe.
Today, research has found that the unexpected, accidental occurrence of the virus invading the central nervous system (CNS) may have to do with muscle trauma:
Thus, the infamous propensity of poliovirus to invade the central nervous system and specifically target motor neurons is rare and accidental and it is neither a prerequisite nor does it present a benefit for its normal life cycle in humans. Poliovirus is a neurotropic virus by mistake; its CNS invasion is mostly a chance event and largely independent of the age, gender, or socioeconomic position of the infected person.
Interestingly, one possible explanation for poliovirus entry into CNS may lie in the association between muscle trauma during viremic phase of poliovirus infection long documented since the earliest epidemics (falls, strenuous activity, intramuscular injections):
It seems that by an unknown mechanism, muscle injury appears to open a portal, possibly at the neuromuscular junction, to allow poliovirus to enter the presynaptic motor neuron terminal.
Another study found that needle pricks increased virus load:
“In mice that received needle sticks, the brain contained an average of 6.4 pool members, 3-fold more virus than untreated mice, suggesting that muscle damage increased poliovirus transport to the CNS.”
Polio’s most famous survivor former President Franklin D. Roosevelt had a remarkably physically strenuous day right before he ‘came down’ with polio:
In August 1921, Roosevelt, then 39, joined his family at their summer cottage on Campobello Island off the coast of Maine and took their 24′ sailboat out on the water with several of his sons. While out, they spotted a forest fire on a nearby island and extinguished it. Returning to the cottage he ran with the children across the island to swim in Lake Glen Severn, followed by a dip in the icy waters of the Bay of Fundy. That night he was too tired to even dress, and went to bed without supper. The next morning he was running a high fever. He would never walk again, without assistance.
More recently, a medical research article proposed that FDR didn’t have polio after all, and had Guillain Barre syndrome, evidence that many paralytic diseases were misdiagnosed during the ‘polio era.’
Vaccine Is Licensed
Based on the field trial results, the federal government’s Secretary of the Department of Health, Education and Welfare at the time, Oveta Culp Hobby, approved the Salk vaccine on April 13, 1955, in a record breaking two hour approval process. Boxes of vaccine doses marked RUSH were sent all over the United States.
Children around the country were getting their first doses as early as April 14th, 1955.
Now, all five manufacturers were in the game, even though only two had their vaccines actually tested on people. NIH would relax its strict safety protocols it had implemented during the field trial to allow more children to get the vaccine, and quickly, as the summertime polio season was approaching. Testing each batch of vaccine would slow the process down. Other safety checks were skipped too.
The new Salk vaccine would no longer contain merthiolate, a mercury based preservative because Salk thought it reduced the efficacy or antigenicity of the vaccine. Mercury has virucidal effects, so removing the preservative would have increased the chance that live virus persists.
Details such as: that the precise vaccine formula for the vaccine being licensed was slightly different than the vaccine used in the ‘field trial’; that not all manufacturers had had their vaccine tested the year before; that a few government scientists were aware that some batches of vaccine inadvertently contained residual live poliovirus but didn’t inform the licensing board–these details didn’t seem to matter.
Concerns about long-term safety of the new vaccine were not even on the radar. There were no issues with the use of monkey kidney tissues in vaccine development either. No questions about the safety of injecting this monkey material into children. They didn’t even know how many children had already had recovered from a poliovirus infection, or had poliovirus antibodies–but some estimates put it as high as 80% of children had immunity to at least one strain of poliovirus.
There wasn’t much consideration of the risks, the future, long term consequences, etc. This was the 1950s, after all.
Eugene Allen Davis Jr., 30 months old, of New Orleans, Louisiana, grandson of New Orleans surgeon Dr. Alton Ochsner, died of bulbar poliomyelitis eight days after his grandfather injected him with the Salk vaccine at his own Ochsner Foundation Hospital to demonstrate the safety of the vaccine. Eugene Allen Davis, Jr.’s sister was also vaccinated with the Salk vaccine at the same time and developed paralysis from the shot. Ochsner’s son would go on to sue Cutter Lab, a company in which his own father was a major stockholder.
Then the reports started coming in. Each day there were more: reports of paralysis, non-paralytic polio called ‘abortive polio’, and even death–all in recently vaccinated children or their close contacts.
On April 18, 1955, Josephine Gottsdanker drove her 5-year-old daughter Anne, and 10-year old son, Jerry, to the pediatrician to get the new Salk vaccine. Josephine watched the nurse take a vial of vaccine out of the refrigerator, draw the vaccine into a glass syringe (this was before disposable syringes), and inject it into the muscle of Anne’s upper right thigh. Minutes later (and guessing the same syringe without sterilization), the procedure was repeated on Jerry.
Less than a week later, on a road trip back home, Anne vomited, and her head was hurting. By the time her parents took her to a hospital, she had lost the ability to move one of her legs, and then the other. Yet her brother appeared fine.
More and more reports of paralysis were reported to health departments from Hawaii, Illinois, Idaho, California and Louisiana.
Janet Lee Kincaid, 7, of Moscow, Idaho died after being inoculated with Salk vaccine from Cutter laboratories.
Susan Pierce, 7, of Pocatello, Idaho died after the Cutter vaccine from the same lot as Janet, and eight other children who were diagnosed with polio in Idaho.
Most of the reports that were coming in had to do with vaccine stock from Cutter Labs. By April 27, about 400,000 persons, mostly children had received their first dose of the Cutter vaccine.
The NIH had a problem on their hands. The Department of Health, Education and Welfare had approved the vaccines by all manufacturers, and no one wanted to cause a panic. Many were in denial. There was ample evidence that a defective vaccine was being given to children, but many of the government officials and members of National Foundation which footed the vaccine development, did not believe there was an issue with the vaccine. They thought children had already been exposed to polio, and this was just a normal polio outbreak, which is what they initially reported to the news media. But this was April. And it’s not polio season.
Finally on April 27, Cutter laboratories voluntarily withdrew their product from the market. In most areas of the United States, vaccination programs halted completely and did not begin again until Fall 1955.
Steven Verbiske, age 7, of Hilo, Hawaii died May 5 after being injected with the Salk vaccine.
While this public health disaster would become known as The Cutter Incident, on June 4, 1955, the New York Times provided some figures of post-vaccination paralysis cases from all manufacturers: Cutter had the most reports of paralysis at 70 cases; Lilly had 37 cases; Wyeth Laboratories, Inc. had 11 cases; Parke, Davis had five cases; and Pittman-Moore had two cases reported.
Clearly, all manufacturers’ products were faulty. In this 2 week period, over 400,000 children received Cutter vaccines, but as many as 4 million people received the Salk vaccine, which may have contained varying amounts of live poliovirus, not to mention the tumor causing virus SV-40, which would not be officially discovered until 1959. The SV-40 virus would be a contaminant in all polio vaccines until the 1960s, but by most reports, it may be a contaminant today, as ongoing tests are not performed. Monkey kidney cells are still used in vaccine development.
Peter Rockne, age 35, of Idaho died May 23 of bulbar polio after his two children received polio vaccine from Cutter laboratories.
The Final Result of the Cutter Disaster
The final tally of what would become known as the Cutter Incident (more aptly named the Cutter Disaster) was: 40,000 children developed ‘non-paralytic polio’, meaning symptoms such as headaches, neck stiffness, muscle weakness, and fever; about 200 children and some close contacts were permanently and severely paralyzed; and 10 died, some children, and some of the victims were the recently vaccinated children’s parents, who caught polio from their child.
“Brooklyn Boy,” age 6, died of bulbo-spinal polio in Brooklyn, New York. The young boy was vaccinated June 2 and became ill July 6.
Disaster Was Preventable
The story isn’t over. One year before the polio vaccines were rolled out to the public, in 1954 government scientist Bernice Eddy was put in charge of testing samples of polio vaccine at her NIH’s Laboratory of Biologics Control. She injected her 18 lab monkeys with vaccines from the five different companies and found that the vaccine from Cutter Laboratories had paralyzed her lab monkeys. Not sure what the cause was, Eddy removed the spinal cords from the monkeys and to her horror, she found live polio virus.
Eddy reported these alarming findings to her boss at NIH, Dr. William G. Workman, that the monkeys who were injected with vaccine from Cutter had developed polio-like symptoms, paralysis and some died. Sadly, this information was not passed on to the licensing boards.
Not only that, Julius Younger, a member of Jonas Salk’s laboratory flew to Berkeley to tour Cutter’s laboratory and was shaken to find that Cutter was growing live polio virus in the same room in which it stored killed vaccine. He noted that their inactivation curves weren’t up to par, its facilities were cramped, and its protocols were illegible or inaccurate, and their notebooks were sloppy. He told Salk about what he saw, but neither of them said anything to anyone else.
Aftermath
It turned out the brand new polio vaccines weren’t properly or consistently “inactivated.” The explanation was that there were clumps of virus that the formaldehyde didn’t reach the center of. Children had been injected with live viruses, and these children had a much higher rate of paralysis than a child who is exposed via the fecal-oral route, from a wild virus.
Cutter Laboratories was held legally responsible for the cases, and by April 1962, 54 of 60 lawsuits brought against the firm had been settled for a total of over $3 million, which is equivalent to $27 billion in today’s currency.
Today, we can’t sue a vaccine manufacturer for injuries, because our government indemnified vaccine makers in 1986 with the Vaccine Injury Act which actually just denies both compensation and causality to victims of vaccine injury.
Human error is palpable as ever in the story of polio.
Ethical Concerns Over Use of Monkeys
It’s hard not to have a problem with the abundant use of animals in research. Up to this point, I have had a very superficial understanding of what that entailed.
In the book The Virus and The Vaccine it reports that Jonas Salk was using 50 monkeys a week in his polio research. Every monkey was anesthetized, killed with ether, and their kidneys removed. Other monkeys had their spinal cord removed. Monkeys that were used at the Rockefeller Institute of Medicine in New York as early as 1910 had been given inoculations intracerebrally of polio infected spinal cord from other monkeys, from humans, etc. Honestly, it’s barbaric what has been allowed to pass under the guise of public health or medicine.
And then to take the kidneys, Salk would blend them in a blender, and add it to other nutrient broths to create the perfect conditions to grow polio virus. If the batch was contaminated by viruses already present in the kidneys, as they often were, and it compromised the purity of the culture, the entire batch would be thrown out. All those monkeys sacrificed for no reason.
This is hard to watch. These are rhesus macaques being used for polio vaccine research in 1956 in the United States:
SOURCES:
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CRONBERG, STIG, and EBBE CRONBERG. “First Description of a Small Epidemic of Poliomyelitis (1808): With an Extensive Case Report from 1807.” Journal of the History of Medicine and Allied Sciences, vol. 20, no. 1, Oxford University Press, 1965, pp. 33–37, http://www.jstor.org/stable/24621477.
- NATHANSON, NEAL; LANGMUIR, ALEXANDER D. (1963). THE CUTTER INCIDENT POLIOMYELITIS FOLLOWING FORMALDEHYDE-INACTIVATED POLIOVIRUS VACCINATION IN THE UNITED STATES DURING THE SPRING OF 1955. American Journal of Epidemiology, 78(1), 16–28. doi:10.1093/oxfordjournals.aje.a120327
- Offit, Paul A. (2005). The Cutter Incident, 50 Years Later. New England Journal of Medicine, 352(14), 1411–1412. doi:10.1056/NEJMp048180
- Lancaster, Karen, et al. Limited Trafficking of a Neurotropic Virus Through Inefficient Retrograde Axonal Transport and the Type I Interferon Response. 2010. https://doi.org/10.1371/journal.ppat.1000791
- Eklund, Carl M. Poliomyelitis in Idaho After Use of Live Virus Vaccine. 1958
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Peterson, Lawrence J. (1955).VACCINATION-INDUCED POLIOMYELITIS IN IDAHO. Journal of the American Medical Association, 159(4), 241–.doi:10.1001/jama.1955.02960210007003
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Francis, Thomas (1955). EVALUATION OF THE 1954 POLIOMYELITIS VACCINE FIELD TRIAL. Journal of the American Medical Association, 158(14), 1266–. doi:10.1001/jama.1955.02960140028004
- Wong M, Connolly AM, Noetzel MJ. Poliomyelitis-like syndrome associated with Epstein-Barr virus infection. Pediatr Neurol. 1999 Mar;20(3):235-7. doi: 10.1016/s0887-8994(98)00142-8. PMID: 10207935.
- Yui LA, Gledhill RF. Limb paralysis as a manifestation of Coxsackie B virus infection. Dev Med Child Neurol. 1991 May;33(5):427-38. doi: 10.1111/j.1469-8749.1991.tb14903.x. PMID: 1648520.
- AN ENDEMIOLOGICAL STUDY OF ENTERIC VIRUS INFECTIONS, 1955
- Steffen Mueller; Eckard Wimmer; Jeronimo Cello (2005). Poliovirus and poliomyelitis: A tale of guts, brains, and an accidental event. , 111(2), 0–193. doi:10.1016/j.virusres.2005.04.008
- McCloskey, Bertram P. (1951). THE RELATION OF PROPHYLACTIC INOCULATIONS TO THE ONSET OF POLIOMYELITIS: A STUDY OF 620 CASES IN THE VICTORIAN EPIDEMIC OF POLIOMYELITIS IN 1949. Medical Journal of Australia, 1(17), 613–618. doi:10.5694/j.1326-5377.1951.tb56369.x
- PROVOCATION POLIOMYELITIS: NEGLECTED CLINICAL OBSERVATIONS FROM 1914 TO 1950 Author(s): H. V. Wyatt Source: Bulletin of the History of Medicine , WINTER 1981, Vol. 55, No. 4 (WINTER 1981), pp. 543-557
- McCloskey, B. P., Gromeier, M., & Wimmer, E. (1999). The relation of prophylactic inoculations to the onset of poliomyelitis. Reviews in Medical Virology, 9(4), 219–226. doi:10.1002/(sici)1099-1654(199910/12)9:4<219::aid-rmv249>3.0.co;2-t
- Steffen Mueller; Eckard Wimmer; Jeronimo Cello (2005). Poliovirus and poliomyelitis: A tale of guts, brains, and an accidental event. , 111(2), 0–193. doi:10.1016/j.virusres.2005.04.008
- Charles K. Mills (1951). The tonsillectomy-poliomyelitis problem. a review of the literature.. , 61(12), 1188–0. doi:10.1288/00005537-195112000-00004
- Krill, Carl E. (1941). MULTIPLE CASES OF TONSILLECTOMY AND POLIOMYELITIS. JAMA: The Journal of the American Medical Association, 117(12), 1013–. doi:10.1001/jama.1941.72820380002009a
- Boy, Jeffrey B Joy PhD, et al. The spread of hepatitis C virus genotype 1a in North America: a retrospective phylogenetic study, 2016. DOI:https://doi.org/10.1016/S1473-3099(16)00124-9
Thank you for your labor of love for the truth. Thank you does not seem enough.
Do you have a P.O. Box where I may send a check as a contribution to your informative work?
Sending warmth, love, & thanks,
Sandy Anderson
(IL)
Thank you so much! You could always share and advocate 🙂 That’s a great way to get the information out. https://circleofmamas.com/store/
I received the Sabin (live attenuated) vaccine in Montreal in 1965. I was 4 years old and became very ill and was paralyzed from the waste down. It wasn’t until about 6 weeks later that I was able to start walking again and I didn’t regain my full leg strength until 2 years later. Apparently there was an outbreak of cases like mine in Montreal, and that was the last time the live Sabin vaccine was used in Canada.