Dr. Salk: A Brief Bibliography
 
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     "It was too quick, said medical colleagues nationwide: Salk had gone public without first publishing everything in the journals.  He rushed out a killed-virus serum without waiting for a safe live-virus one, which would be better.  Doctors walked out of professional meetings; some quit the foundation that funded the testing.  Salk was after personal glory, they said.  Salk was after money, they said.  Salk was after big prizes.
     "Salk tested the serum of five thousand Pittsburgh schoolchildren, of whom I was three, because I kept changing elementary schools.  Our parents, like ninety-five percent of all Pittsburgh parents, signed the consent forms.   Did the other mothers then bend over the desk in relief and sob?  I don't know.  But I don't suppose any of them gave much of a damn what Salk had been after.

—Annie Dillard, Polio Pioneer
quoted in
Patenting the Sun:
Polio and the Salk Vaccine

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In 1954, the decision was made to conduct a wide-scale test of the vaccine.  It was not made easily.  Although Salk had had nothing but positive results, no one knew for sure that the vaccine would provide long-term immunity.   What if the effect was temporary and people relaxed their guard?  What if the fluid in which the virus was suspended could cause allergic reaction or cancer?  What if?  What if?  What if?  But, as Basil O'Connor pointed out, what if they did nothing, and another 30,000 children were stricken in the coming summer?1

That spring, almost two million children in forty-four states took part two studies of the polio vaccine.  One study was an observed-control study: in 33 states, every second grader who volunteered got the vaccine and they would be compared to unvaccinated first and third graders.  Another study would be double-blind: in counties in eleven other states, half of the first-, second-, and third-grade volunteers would get the vaccine and the other half would get a shot of pink-coloured water.2   No one would know who got which except the data analysts at the Vaccine Evaluation Center at the University of Michigan in Ann Arbor. 

Because no one knew where polio would strike that summer, children all over the nation had to receive the vaccine.  Over 650,000 children would get either a dose of gamma globulin containing killed virus from all three polio serotypes or an injection of pink water.  The doses would be administered three times.  Another 1.2 million children would be part of the observed control group.   At the end of the summer, researchers would examine the medical records of almost two million children, and, they hoped, the children who got the vaccine would have had a much lower incidence of polio than the unvaccinated controls.3  

The subject children were called Polio Pioneers.  It might seem hard to imagine today that parents would allow their children to be in a medical experiment, but in fact there were more volunteers than were needed.  The growing threat of polio loomed like a spectre over the nation, and the vaccine, even an unproven vaccine, offered hope.4 

pioneers.gif (35552 bytes)
Children line up to take part in the vaccine trials.

The trials cost over seven million dollars.  Five and a half million dollars of that went to buy one million doses of gamma globulin from the Department of Defense.  It was the entire nation's supply.  Some people were outraged at the cost of the trials.  Basil O'Connor calculated that it would cost $7000 per case of polio it prevented, assuming the vaccine worked.  He also knew that it cost the National Foundation $40,000 to care for a single paralyzed person for the rest of his or her life.  It seemed like a reasonable return to him.  Others felt the trials were being held too soon.  They said that the people Salk had already inoculated should be studied for fifteen to twenty years before the vaccine was tested in the general population.  O'Connor did some more calculations; at fifty thousand cases per year, twenty thousand resulting in paralysis, that was one million victims in twenty years, with four-hundred thousand paralyzed.  That was simply too much.  Salk had conducted three trials without adverse affects.  They couldn't wait.5

The trials were enormous.  After it was over, the PTA, which had provided community volunteers, estimated that 300,000 volunteers had been used.  The trial required 1.2 million needles.  Two sets of blood work were performed on 40,000 children (2% of the inoculated).  One hundred thousand sets of teacher instructions were prepared for the observed group and 37,500 for the inoculated areas.  Hundreds of millions of documents, along with press releases and public statements, and even a film designed for the six years olds who would receive the shots flowed out of the headquarters of the National Foundation.6 

The trials were not without problem.  In one area, the vials got scrambled, and some children got placebo for one shot and vaccine for another.  In another, one doctor separated the vials from the control codes that would identify the vaccine and placebo to the evaluators.  In Denver, classed as the premier field-trial city because it had the highest participation of eligible children, the registration papers had been filled out incorrectly.  The evaluators were prepared to throw out all of the meaningless data, but teachers gave up their summer vacations to repair the registration papers.7

By June of 1954, all of the shots had been given and all of the paperwork had been submitted to the Vaccine Evaluation Center.  All that remained was to sit back and wait for the summer to pass, to count the paralyzed and the dead, and crunch the numbers. 

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Footnotes

1.  Seavey, Nina Gilden, Jane S. Smith, & Paul Wagner.  A Paralyzing Fear: The Triumph over Polio in America.  New York, New York: TV Books.  1998.   p. 171.

2.  Smith, Jane S.  Patenting the Sun: Polio and the Salk Vaccine.   New York, New York: William Morrow and Company, Inc.  1990.  p. 229.

3.  idem.  pp. 177-178.

4.  idem.  pp. 157-158.

5.  idem.  pp. 174-175.

6.  idem.  pp. 237-238.

7.  idem.  pp. 270-272.