Salk IPV Polio Vaccine Field Trials of 1954
http://www.time.com/time/magazine/article/0,9171,889643,00.html [ Time magazine Feb.09,1953]
“There was solid good news on the polio front last week….a way has been found to treat polio virus with chemicals”…
Dr. Harry Weaver (PhD) of the National Foundation for Infantile Paralysis : ” ‘I would like to be able to announce that field tests with such a vaccine will be undertaken during 1953,’ Dr. Weaver went on, but he could not say this for certain. Nevertheless, he had the feeling that the attack on polio was about to make a big advance.”
Weaver made his own advance to the American Cancer Society, replaced as director of polio research in May 1953 by Rockefeller alumni Dr
. Henry Kumm http://whale.to/m/kumm.html
The Francis Report was a Salk IPV vaccine efficacy evaluation involving over 1,800,000 children in two years’ time, most all in 1954.
Participants were divided into 4 categories:
Vaccine – recipients received the full three-dose set of inoculations
Placebo – recipients received the full three-dose set of placebo
Incomplete vaccine – one, two, but not the third dose of vaccine
Incomplete placebo – one, two, but not the third dose of placebo
A “Not Inoculated” category refers to children who did not participate in getting injections, meant to serve as ‘controls’, BUT includes 8,577 children who received “Incomplete Placebo”. The IPV placebo was identical to the vaccine absent the poliovirus, containing formaldehyde and mercury. “Without Merthiolate, Salk argued, the polio vaccine should be 100 percent effective.”
The field trials were conducted with the help of 20,000 physicians, 40,000 nurses, 14,000 school principals, 50,000 teachers, and 200,000 volunteers; over 300,000 personnel. Dr. Ralph Scobey who testified to Congress in 1951 that neurotoxins were causing the epidemics of polio, called it “the largest medical experiment in history”. Double-blind, placebo controlled studies for drug evaluation were relatively new. The gamma globulin field trials for polio in 1951-52 using over 54,000 children [Provo Utah page] were among the first.
“The trial at the time cost $7.5 million. Today, it would cost $3 billion – roughly the entire market for vaccines in the U.S.,” said Dr. Paul A. Offit, chief of infectious diseases at the Children’s Hospital of Philadelphia.” http://www.signonsandiego.com/uniontrib/20050412/news_1n12polio.html
“I remember bringing home information from school requesting children to participate in the tests. My parents had a terrible fight over it. My Mom was against it but my Dad was convinced it couldn’t hurt and maybe help. For a change, he won out and I became a Polio Pioneer. I remember lining up in the school cafeteria with nurses in old fashioned nurse uniforms with hats, giving us the shot and then a lollipop. It’s a good thing I participated and got the real vaccine instead of a placebo because that summer I became deathly ill.” –Henry Broder http://www.polio.umich.edu/history/memories.html
Article by Marcia Meldrum, published in the British Medical Journal, Oct.1998 –“A calclated risk: the Salk polio vaccine field trials of 1954”
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1114166/ [excerpts below]
“On 9 November 1953, O’Connor announced that the field trials would begin in the spring and that an “observed control” plan would be used, in which one group of children would receive vaccine, while others in the same age group would not be injected but only observed.10
Hart Van Riper, the foundation’s medical director, asked the nation’s health officers for advice and support.11
Carrying the imprimatur of medical expertise, yet necessarily responsive to public fears, the health departments constituted a potential counterweight to the virology community.
Within a month, departments in 38 states had responded, most enthusiastic about the prospect of a vaccine and ready to use the observed control plan. A number of state officials, however, saw it as a problem that the project was sponsored not by scientists but by a lay organisation. They questioned the impartiality of an evaluation run by the foundation and the rigour of the proposed design.3,12
To meet these objections, and those of the doubting virologists, O’Connor and Van Riper asked Thomas Francis of the University of Michigan to direct an independent evaluation of the trials, supported by funds from the foundation, but otherwise autonomous.3,4,13,14
Francis, a highly respected virologist who had conducted field trials of influenza vaccines, was supportive of the killed virus preparation. “I think I shall do it,” Francis admitted in a letter on 29 December15
; but before taking the job, he mobilised support among the state health officers to engineer a change in the trial design.”
“In a public statement on 8 January 1954, the foundation still adhered to the observed control plan; but on 15 February, six days after Francis was formally appointed to head the evaluation, O’Connor announced that two types of controls would be used in the field trials: “observed controls” in 34 states and “placebo controls” in 11: “a combination of the two procedures [will] assure a valid evaluation of the trial vaccine.”16,17
This change in plans was the result of a month of manoeuvring on Francis’s part.”
“He had requested an “advisory group” meeting on 11 January. This new group was entirely distinct from the foundation’s scientific advisory committee, which was excluded from these deliberations. As well as the senior staff of the foundation, a selected list of state health officers, paediatricians, clinical polio specialists, statisticians, and virologists attended. Their charge was not to debate the merits of Salk’s work but to take the vaccine project from the laboratory into the field. Part of the January group later became an advisory committee for the field trial evaluation, and the state health officers constituted a separate body to advise on “technical aspects” of the project.1,18,19
Because the health officers were divided, Francis’s role was critical.”
….”Francis himself joined the “health officers” group. He listed in his notes several health departments that would support an injected, or placebo, control design: Massachusetts, New York, Michigan, Ohio, Illinois, California. Each was a populous state with a well organised health department headed by a nationally respected physician. Perhaps, he mused, a “double study” could be done in these states: placebo controls in the second grade, observed controls in the first and third grades.20“
…”In Francis’s mind, the placebo control study was now his primary interest, and he reiterated this point in the summary report. Indeed, he seems to have stage managed the January meetings to reorient the project in that direction, selecting likely allies among the health officers and using their support to rewrite the trial design. “The best Departments are committed to this [placebo control] plan,” Francis told Van Riper. “The assurance and faith of those committed must be maintained.”
…..”If the Salk vaccine trials were to succeed, it was essential that they be a great national event, enlisting volunteers, doctors, and parents in one united effort that represented the culmination of 15 years of work and faith. Given the climate of scientific doubt that surrounded the killed-virus vaccine, it was essential that the field trials offer public, as well as scientific, validation of its effectiveness.”
The ATOMIC BOMB Survivor’s Study – http://radepicourse2007.cancer.gov/content/presentations/slides/PRESTOND_slides.pdf
Hiroshima was leveled by 16 kilotons of U-235 (enriched uranium)
Nagasaki was crushed by 22 kilotons of Pu-239 (plutonium)
Unclassified documentation reputedly began in 1950.
Francis reorganized the efforts of the Atomic Bomb Casualty Commission (ABCC) to produce epidemiological data, until 1957, when directorship of the ABCC was taken over by George B. Darling (Yale) http://www7.nationalacademies.org/archives/ABCC_1945-1982.html . In the early 1970s, the Japanese government’s Institute of Health was invited to join the study, which changed it’s name to Radiation Effects Research Foundation (RERF) http://dels.nas.edu/nrsb/rerf.shtml
“In September 1945, the U.S. Army, the Navy, and the Manhattan District sent teams to Hiroshima and Nagasaki to study the medical effects of the atomic bombs. These were headed by Col. Ashley W. Oughterson for the Army, Capt. Shields Warren for the Navy, and Col. Stafford L. Warren for the Manhattan District. By order of General Douglas MacArthur, the Supreme Commander, these units and the Japanese groups under Dr. Tsuzuki were merged on October 12, 1945 to form the Joint Commission for the Investigation of the Effects of the Atomic Bombs. The American personnel consisted of more than 60 specialists. Dr. Tsuzuki assembled more than 90 Japanese physicians and scientists. A preliminary report was issued by the Joint Commission; however, the vast amount of data collected was filed as a series of classified reports, some of which were published much later (9). Nonetheless, it was soon clear that a careful long term follow–up study of the survivors and their children was needed and that the Joint Commission set up by the military was not the appropriate agency to do this.”
…”One recommendation of the conference was for “the establishment of a permanent organization for continuing long term study of the biological and medical effects of the atomic bomb.”
The Atomic Bomb Casualty Commission received a Presidential charter from Truman in November of 1946.
“The first laboratory was established in coaches on a train that the U.S. military had set up to handle unexpected disasters or possible epidemics (Fig. (Fig.2). From January 1948 until 1950, ABCC was located in a requisitioned building (the Gai-sen-kan) in Hiroshima. Finally, in 1950, a permanent laboratory consisting of modified Quonset huts was constructed on the top of Hijiyama Hill overlooking the gutted city (Fig.3). These buildings remain to this day, as does the controversy about their site, which had a Shinto memorial and a military cemetery”….”The first decade of ABCC [1947-1957] was a period of uncertainty, marked by some important accomplishments but marred by financial problems and lack of a clear scientific direction.
…”The NRC–NAS Committee on Atomic Casualties in the Division of Medical Sciences had the initial responsibility for oversight of the ABCC program. The Committee was founded on March 1, 1947 and held its first meeting March 25, 1947… This first meeting was attended by representatives of the armed services who gave reports on the observations made thus far and offered suggestions on how the future investigation should be designed and conducted. Dr. Thomas M. Rivers [was] the Chairman“…[Rivers was the director of RIMR and Chair of the March of Dimes]
“As increasingly negative findings accumulated and the Korean War (1950–1953) began…[e]ven Detlev W. Bronk, then President of NAS and an early supporter of ABCC, now voiced concern…[The] CAC, on February 3, 1951, voted to terminate ABCC (CAC Minutes). The motion ordered “that the ABCC be discontinued because of lack of financial support.”…”However, lingering doubts remained that prompted a thorough review of the entire program by an NRC–NAS committee, later known as the Francis Committee.”
[The Nevada Proving Ground (NTS) became operational one month before the ABCC was terminated, in January 1951 with its first test series ‘Operation Ranger’. Radioactive snow was subsequently sampled in Ann Arbor, MI, and Dr. W.M. Hammon was allowed to proceed with gamma globulin –see ‘Provo Utah’ page–in lieu of a medical public health measure ]
[In the fall of 1955, a] committee was formed that came to be known as the Francis Committee. The committee was chaired by Thomas Francis, Jr., an eminent epidemiologist and virologist, from the University of Michigan. The other members were Seymour Jablon of the Follow-Up Agency, NRC–NAS, and Felix E. Moore, from the National Heart Institute. Accompanied by Cannan, the committee made a 3–week visit to Japan in October, 1955 and conducted an intensive review of the objectives of ABCC and of its research program (17
). Their report, the “Francis Report,” made sweeping recommendations for reorganization of the program and for focus on integrated epidemiological and genetic study of a fixed population defined by a “Master Sample”…
“In 1956, members of the Francis Committee returned to Japan for 7 weeks to consult on implementation of the Unified Study Program. In August, four U.S. Public Health Service (USPHS) physicians were assigned to ABCC—the first of many who later served with ABCC. In 1957, Japanese physicians were appointed as Associate Directors at Hiroshima and Nagasaki. One of the most important events was [Dr. R. Keith Cannan, NYU biochemist and exec. director of the ABCC] Cannan’s recruitment of Dr. George B. Darling as Director of ABCC in June 1957.”
Robert Keith Cannan (1894-1971)
The TECUMSEH Community Health Study, organized in 1957 during peak atmospheric fallout