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Thanks and Remembrance: The Polio Volunteers.

Posted on | November 24, 2020 | 6 Comments

With my sister, Pat – “Polio Volunteer.”

Mike Magee

With vaccines and new leadership now on the horizon, it’s useful to acknowledge that this is not our first pandemic. Of course there was the 1918 flu, but before that – and for many years  after – there was polio.

Two years into his first term as President, in 1934, FDR hosted his first “Birthday Ball” and raised one million dollars for his Georgia Warm Springs Foundation – the site he returned to again and again for rehabilitation after contracting the debilitating disease.

He continued the yearly events and four years later in 1938, he broadened the effort creating the National Foundation for Infantile Paralysis (NFIP). To this mix, FDR added two additional resources – great management and celebrity support.

Management came in the form of Basil O’Connor, attorney and close friend of the President. Their friendship predated FDR’s polio and included O’Connor serving as his legal adviser and for a brief period of time as his partner in the practice of law. He would serve loyally in that capacity for more than three decades.

O’Connor’s first order of business was to set up an organizational structure with reach across the country to support services and fundraising. Ultimately, 3100 chapters would be established and $233 million distributed in patient services for children with polio by 1955.

Much of that funding came from a unique idea first presented by radio personality and FDR supporter, Eddie Cantor. Singer, dancer and comedian, he went by the label “Apostle of Pep”, and matched energy level with FDR, stride for stride. At the time Cantor became involved in the Foundation, he had just completed a term as the president of the Screen Actors Guild. In that capacity, he was very familiar with a radio series and accompanying theater newsreel programs titled, “The March of Time”.

Narrated by radio pioneer Fred Smith, and funded by TIME magazine, the program was the first of its kind “dramatized news format” complete with sound effects and music. In January, 1938, Cantor went on his regular radio show and announced the “March of Dimes”, a take-off on the popular newsreel show name. He asked his viewers, young and old, to mail a dime to the President to help beat polio. His many celebrity friends chimed in, amplifying the name and the message, and the “March of Dimes” brand was born. Nearly 3 million dimes arrived at the White House with that first drive, raising 268,000 dollars in change.

Jonas Salk was recruited to the University of Pittsburg in 1947. In 1948, he received a grant from the National Foundation for Infantile Paralysis (NFIP) to identify the various types of polio. But Salk’s goals were much more expansive. He intended to develop the first successful vaccine for the disease and devoted the next seven years to that effort.

Fully funded by the NFIP at $7,500,000, and therefore requiring no need to be distracted by fund raising, Salk initiated a trial on 15,000 children in Allegheny County, Pennsylvania in 1953. The decision to stay close to home vastly simplified the logistics and avoided extra red tape. It didn’t hurt that he also tested himself, his wife and his children or that he achieved startling results on his first try out. Blood drawn from his subjects revealed antibody levels to polio that were 4 to 16 times the levels in non-treated children. These results were reported out in the Journal of the American Medical Association on March 25, 1953.

Following this announcement, which received worldwide attention, Salk took two additional steps that clearly demonstrated both his political and scientific prowess. First he went to Basil O’Connor at the NFIP and secured 100% funding for the largest scientific study that would ever be run in the US. In addition to securing that funding, he enlisted the vast marketing expertise and distribution system of the NFIP.

Secondly, rather than design the trials himself, at a time when scientific competitors were nipping at his heels, Salk enlisted his very popular and highly respected former mentor, Thomas Francis, to design and run the trials. Besides his scientific reputation, Francis had a distinguished record of public service having been the director of the Commission on Influenza for the Army Epidemiologic Board. By 1953, he was a renowned virologist and chair of the epidemiology department at the University of Michigan’s School of Public Health. Once Basil O’Connor with Salk chose Dr. Francis, they carefully created a firewall between themselves and the scientific trials.

Francis was fully aware of the deficiencies in the design. Did every parent clearly read the permission material? Clearly not.Was defining the trial’s purpose “to determine the effectiveness of a vaccine in preventing paralytic poliomyelitis” understating the trial’s experimental nature? What sufficed as a “valid parental signature”? Why were the terms “permission” and “human experiment” found nowhere on the consent form? Was Basil O’Connor’s letter on behalf of the NCIP that accompanied the parental materials and defined their child as having been “selected to take part in this great scientific test” overselling? And did he consciously underplay risk and deliberately transfer liability when he capitalized the words “THE VACCINE WILL BE GIVEN ONLY ON REQUEST OF THE PARENTS” in his letter?

My doctor father received a parcel post in his office in the Spring of 1954. It contained indistinguishable vials of the vaccine and placebo. He used the materials to inject the 2nd graders at our school, including my sister Pat. The event was memorialized in a front page photo in the local Hudson Dispatch of my father, needle in hand, and Pat wincing from the shot, but also proudly displaying her button and card declaring her a “Polio Pioneer”. That was Basil’s idea, as it was to give all the children who participated, including the controls who received no injections, buttons as well. In his view, no one should feel left out of this national public effort to beat the enemy – Polio.

The study remains controversial to this date with two arms – randomized and observed control. The former served the needs of scientists, while the later was felt necessary to maintain public support. In the randomized arm, 2nd graders either received the active vaccine or a placebo, and 1st and 3rd graders were left untreated and served as “controls.” In a second observed control model, all 2nd graders received the vaccine.

The end results were startling and have never been replicated since. Beginning April 26, 1954, within a year’s time, 1.8 million children in 15,000 schools in 44 states were recruited for the experiment. 300,000 health professional volunteers, including my father and the majority of the physicians in the United States, participated without pay. 750,000 of the children – all 2nd graders form public and private schools – were part of a rigorous double blind study.

It was Dr. Francis who stood up on April 12, 1955 at 10:20 AM in Rackham Lecture Hall at the University of Michigan in Ann Arbor and declared in his characteristic direct style, “The vaccine works. It is safe, effective and potent.” 

Comments

6 Responses to “Thanks and Remembrance: The Polio Volunteers.”

  1. Nancy Menzel
    November 25th, 2020 @ 9:31 am

    How could it be “double blind” if the controls received no injections?

  2. Mike Magee
    November 25th, 2020 @ 11:08 am

    Good question, Nancy. As this BMJ article outlines in 1998, there was actually a dual protocol. One arm was double-blinded (vaccine vs. placebo), while in the other, all 2nd graders received the vaccine, and 1st and 3rd graders served as controls. BMJ (https://www.bmj.com/content/317/7167/1233) writes: “The polio vaccine field trials of 1954, sponsored by the National Foundation for Infantile Paralysis (March of Dimes), are among the largest and most publicised clinical trials ever undertaken. Across the United States, 623 972 schoolchildren were injected with vaccine or placebo, and more than a million others participated as “observed” controls. The results, announced in 1955, showed good statistical evidence that Jonas Salk’s killed virus preparation was 80-90% effective in preventing paralytic poliomyelitis.1

    The statistical design used in this great experiment was singular, prompting criticism at the time and since. Eighty four test areas in 11 states used the textbook model: in a randomised, blinded design all participating children in the first three grades of school (ages 6-9) received injections of either vaccine or placebo and were observed for evidence of the disease. But 127 test areas in 33 states used an “observed control” design: participating children in the second grade (ages 7-8) received injections of vaccine; no placebo was given, and children in all three grades were then observed for the duration of the polio “season.”1

  3. Charles Fahey
    November 25th, 2020 @ 11:27 am

    As always, thank you. Happy thanksgiving to you and all dear. Many including myself should be and are thankful to you.

    Peace and all good things.
    Chuck

  4. Mike Magee
    November 25th, 2020 @ 11:30 am

    Blessings, Chuck! Thinking of you this Thanksgiving, and the learnings and insights you have provided over the years of our friendship. Best, Mike

  5. Jill Stewart
    November 27th, 2020 @ 9:15 am

    Mike: wonderful, timely story. As a Pittsburgher, we’ve always been proud of our role as host to Dr. Salk and his work. Life-changing for our generation and beyond!

  6. Mike Magee
    November 27th, 2020 @ 10:19 am

    Absolutely, Jill! Pittsburg has always been, and will always be, amazing on many scales – science being one!

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