The NF/MOD Timetable for the Salk Vaccine(s)

As noted in Part II, Dr. Jonas Salk was only one of the many polio researchers funded by the NFIP, now better known as the National Foundation/March of Dimes (NF).

In 1948, the NF established the Virus Research Laboratory at the University of Pittsburgh and began funding Jonas Salk’s research on an “inactivated” or “killed” polio vaccine.[1] It was also funding Dr. Albert Sabin’s work at the University of Cincinnati on a “live” or “attenuated” oral polio vaccine which was greatly favored by virologists at the time.[2]

In 1949, Salk began his unpublicized research on the technical problems associated with a killed vaccine using formaldehyde as the killing agent. The following year he began tissue-culture production of the polio virus. By 1951, the NF was investing $200,000 a year to promote Salk’s research program.[3]

Much of the initial laboratory investment time and resources were devoted to polio virus typing. There were three serotypes of poliovirus – 1, 2, and 3. Type 1 causes about 85% of paralytic cases; type 2 represents only about 3% of paralytic cases; and type 3 causes about 12% of paralytic cases. Any effective polio vaccine needed to be “trivalent,” that is, effective against the three different strains.[4]

Salk’s Various Polio Vaccine “Recipes”

Thanks to the research efforts of Dr. Paul Offit, author of The Cutter Incident (2005) we know today what was kept highly secret in Salk’s time, that is, the major ingredients that went into various Salk vaccine “recipes.”

According to Offit, in order to combat type 1, the primary cause of paralytic polio, Salk selected one of the most virulent and dangerous strains – the Mahoney strain – for its potential effectiveness. But this “benefit” was offset by the fact that his “killed vaccine,” using formaldehyde to inactivate the Mahoney virus, did contain small amounts of live particles of the deadly virus.[5] The remaining weaker strains – MEF-1 strain for type 2 virus and the Saukett [Sarkett] strain for type 3 virus appeared to be easier to inactivate.[6]

Although Salk touted that his polio vaccine was “one of the simplest biological preparations to make,”[7] in fact, it turned out to be “one of the most complex biological preparations ever to be made.”[8]

Starting in 1952, Salk was able to carry out quasi secret vaccine trials, including the use of the Mahony strain, on his first human guinea pigs – not himself or his children – but the children at the D.T. Watson Home for Crippled Children [Watson Institute] which was home to a number of young polio patients, and the Polk State School for the Mentally Retarded (established in 1897).[9]

As reported by Offit, the vaccines administered at the Watson Home containing type I or type 3 did not produce any polio antibodies. Only the vaccine containing type 2 virus induced polio antibodies.[10] In other words, this particular Salk vaccine recipe was most affective against the least dangerous polio virus.

Salk was more successful at the Polk State School where the retarded children were given a different vaccine containing mineral oil as an adjuvant that enhanced immune response. This particular recipe produced antibodies to all three types of polio virus.[11]

On January 23, 1953, while continuing his testing in the Pittsburgh area, Salk revealed the preliminary data of his polio vaccine to a Round-table Conference of the NF held in Hershey, Pennsylvania.

During that same spring and fall of 1953, Salk continued testing in the Pittsburgh area among family groups and volunteers including himself and his own family members.

In the fall of 1953, O’Connor began NF negotiations with the drug manufacturers for the production of the Salk Vaccine for large scale trials despite strong opposition from Dr. Sabin, and Drs. John R. Paul and Joseph L. Melnick of Yale.[12] And on February 1954, ignoring all warning signs, the NF committed $7.5 million to national trials of Salk Vaccine and $9 million in purchase guarantees to the vaccine manufacturers. This meant they had the financial risk taken out of vaccine research and development.

The pharmaceutical companies that were enticed to make the vaccine for the field trial were Parke-Davis, Detroit; Eli Lilly, Indianapolis; Wyeth Laboratories, Marietta, PA; Pitman-Moore, Zionville, IN; and Cutter Laboratories, Berkeley.[13]

1954 Field Test Used a Modified Salk Recipe

As reported by Offit, the modified Salk vaccine used in the 1954 field testing no longer contained mineral oil, and it was made using monkey kidney [not testicular] cells. Also, an anti-bacteria adjuvant, Merthiolate was added, which Offit does not mention in his book, but which was to play a critical role in the suppression of the effectiveness of Salk’s 1954 vaccine – making it “safer” but less “potent” and “effective.”

Other changes by Salk included a more diluted formaldehyde, and an increase in the “cooking” temperature used for the inactivation process. It was at about this point that Salk publicly enunciated his “straight-line theory” on deactivation which, according to Offit “defined the relationship between the quality of infectious virus and the length of time that the virus was treated with formaldehyde.”[14] According to Salk’s theory, “for all practical purposes, treatment for nine days would completely inactivate the polio virus.”[15]

But what if Salk’s “straight-line theory,” did not hold up especially in the case of virulent strains of the polio virus like the Mahony virus? What “if instead of a straight-line, the line curved back toward the baseline” indicating that the live virus was not entirely inactivated and continued to be present in the vaccine?

Unfortunately, this turned out to be the case when fellow researchers tried to duplicate Salk’s inactivation procedures to the letter. They discovered that the polio virus had not been thoroughly inactivated, but remained in sufficient amounts to paralyze laboratory monkeys.

Among the researchers that challenged Salk’s inactivation measures using formaldehyde were Dr. Albert Milzer[16] of the Michael Reese Hospital in Chicago, and virologist Sven Gard of the Karolinska Institute in Sweden. The latter indicated that his studies showed that inactivation by formaldehyde treatment for necessarily longer periods of cooking time – up to 12 weeks – did not run the course of a [straight-line] reaction but started to curve, meaning the vaccine was capable of also paralyzing human beings.[17] But the warnings for extreme caution were ignored by Salk and the NF.

Salk consistently responded to his critics that researchers like Milzer and Gard failed to follow his exact methods of inactivation:

… we can state flatly that the vaccine as prepared by us is devoid of any infective virus and that no human being has been, or ever will, in any field trials, be inoculated with any material that has the remotest suspicion attached to it.[18]

Early Manufacturing Problems With the 1954 Vaccine

As noted earlier, it was the NF, and not the U.S. government, that was in charge of performing the first large scale field testing of the continuously modified Salk vaccine.

Amazingly, even before the start of 1954 trials, the NF was already well aware that two of the more experienced manufacturers of the Salk’s “killed vaccine,” Parke-Davis and Eli Lilly were having difficulty in completely inactivating the dangerous live viruses using Salk’s protocol.[19]

As documented by Dr. Ratner:

Dr. Salk here [above statement on safety of his vaccine] and through the whole subsequent course of the Salk vaccine dispute keeps insisting on the infallible ability of his laboratory to assure a vaccine devoid of any infective virus. This infallibility is belied by the 1954 testing of field trial Salk vaccine for the presence of live virus. Dr. Salk’s laboratory was one of three laboratories testing for live virus in the vaccine. In five instances (Lilly lot 301, Parke Davis lots 501 and 504, and Wyeth lots 207 and 208), Salk’s laboratory failed to find live virus either by monkey test or tissue culture test though virus was found with these tests by the manufacturer and/or NIH. This confirms other evidence that Dr. Salk did not in fact know whether the vaccine prepared by him – so called ‘properly prepared vaccine’ – contained live virus or not. Because of this, his many publications … claiming persistence of antibodies stimulated by his ‘killed’ vaccine, are invalid.[20]

The unfortunate and immediate whistle blower, at this critical juncture was William Workman, Director of the Laboratory of Biologics Control.

On March 22, 1954, just weeks before the field trial was to begin, Workman sent Jonas Salk a letter recommending the field test be postponed until the safety of the vaccine could be insured.[21] Panic ensued at the NF and an emergency meeting was called between NF President O’Connor and Dr. Thomas Rivers, chief scientific advisor to the NF, and high level NIH officials including Dr. James Shannon, Assistant Director of the NIH and Dr. Victor Haas, Workman’s boss, who was head of the National Microbiological Institute.[22]

Although both Shannon and Haas opposed the passing of the vaccine that the latter considered “dangerous,” after heated negotiations, the will of the NF prevailed over the safety of the nation’s children. The only saving proviso that the NIH mandated was that “companies had to make eleven consecutive lots of vaccine that passed safety tests before their manufacturing methods could be accepted with confidence.”[23] As it turned out, only Parke-Davis and Eli Lilly eventually met this requirement in the production of the 1954 field trial vaccine. Later, both Shannon and Haas would come to regret their decision to cave into the demands of the NF.

And so it was that on April 26, 1954, all warnings were put aside by the USPHS and the NIH under pressure from the NF, and the single field trial testing of the Salk vaccine began. The cost to the NF was $7.5 million. The inoculation program introduced in the U.S., Canada, and Finland was “the largest, most comprehensive test of a medical procedure ever performed.”[24] The actual figure of candidates who received the 1954 Salk vaccine was 420,000.[25]

More Red Flags Raised at the NIH

That very same summer, sample batches of the Salk Vaccine were making their way swimmingly through various U.S. medical research government check points in anticipation of the upcoming 1955 nation-wide campaign, the vaccine once again ran into a serious blockade at the NIH’s Laboratory of Biologics Control (LBC).

Veteran virologist and epidemiologist, Dr. Bernice Eddy was assigned the advanced task of evaluating batches of the Salk vaccine being manufactured by Parke-Davis and Eli Lilly and three other pharmaceutical houses including the Cutter Laboratories, who had already been approved by the NF.

Disaster struck when Eddy discovered that one [eventually three] of the Cutter batches contained the deadly Mahony virus which had resulted in 18 test monkeys being paralyzed not immunized. She initially thought the problem lay in the manufacturing process rather than in the Salk protocol itself.

Eddy quickly passed the information on to her immediate superior, William Workman, head of the LBC, who was already well aware of the problem. Workman, in turn informed Dr. William H. Sebrell, Jr., Director of the NIH, of Eddy’s findings.[26] Whoever else was informed of Eddy’s discovery is unknown, but we know for certain it was not anyone outside the NF/USPHS/NIH/Salk loop including public health officials and the general public.

In the meantime the LBC staff continued their intensive investigation through November of 1954.[27]

As for the fate of the whistle blower and recently widowed and mother of three, Bernice Eddy, instead of being promoted for her critical discovery, was demoted, and returned to her previous job researching flu viruses. But she would later inadvertently sock it to the NF again, when in 1958-1960, she discovered the Simian Virus 40 (SV) found in monkeys and present in the “inactivated” Salk vaccine, was shown to induce cancerous tumors when injected into hamsters.[28]

Fraudulent 1954 Field Trial Evaluation

The evaluation of the 1954 field trial was carried out by Salk’s mentor, Dr. Thomas Francis, at the University of Michigan Polio Evaluation Center, Ann Arbor.

Unfortunately, the entire effort as recorded in the summary and final reports was fraudulent due to a clever redefinition and reclassification of the disease (indeed a new disease was created), and the manipulation and altering of statistics, as detailed by Dr. Bernard G. Greenberg at a panel exposition on the status of polio vaccines that took place at the 120th annual meeting of the Illinois state Medical Society in Chicago on May 26, 1960.[29]

The “Francis Report” Upholds the Salk Vaccine

On April 12, 1955, at an audience at the University of Michigan’s Rackham Auditorium packed with hundreds of national and international reporters and TV cameramen, government officials, and NF/MOD officers including Basil O’Connor, Dr. Thomas Francis presented The Francis Report – An Evaluation of the 1954 Field Trial of Poliomyelitis Vaccine [Salk Vaccine] Summary Report. The key word in the title is “summary.” The report contained no hard data. That would not be forthcoming for another two years.[30]

Nevertheless, Francis pontificated that Salk Vaccine field trial of April 1954, which had been shrouded in secrecy, was a great success, and that the vaccine was “safe, effective, and potent.” Francis informed the media and NF guests that the Salk vaccine was 60 to 70 percent effective in preventing infection with type 1 poliovirus, the most prevalent strain, and at least 90 percent effective against types 2 and 3.[31]

However, much to Francis’ shock, when Salk took the microphone to address the audience, he took exception to Francis’ statement on the effectiveness of his vaccine. Salk publicly challenged Francis’ findings and declared that any failures encountered in the 1954 trial were not his fault. He said the failures were caused by Merthiolate, a mercury-based antiseptic that had been added to the batches of vaccine, against Salk’s wishes, at the express orders of the Laboratory of Biologics Control.”[32] Thus we have Salk admitting that Merthiolate destroyed the antigen-production of the type 1 virus, the type that causes most paralytic polio. In hindsight, however, the Merthiolate, may have saved the lives of many children by destroying the deadly Mahoney virus and making the vaccine “safe,” but ineffective, in preventing paralytic polio.

By way of compensation, Salk went on to explain that he had reformulated a new and improved (Merthiolate-free) vaccine that might well be 100 percent effective.[33]

Unfortunately, in the frenzy of the day, no one, including any public health official or attending physician or reporter appeared to have been the least curious so as to ask Salk for more details on his new second-stage vaccine, or to inquire if additional field studies and testing of the “new and improved” vaccine were required before it was licensed for nationwide distribution.

Instead, “Doc” O’Connor saved the day for the Salk vaccine by declaring that the NF/MOD had finally conquered polio. Media chaos prevailed. The world was elated and fell to its knees in gratitude to Salk and the NF.

Salk Vaccine Licensed For Nationwide Distribution

Less than three hours later on that same day, August 12, 1955, the federal Vaccine Licensing Advisory Committee, officially approved the “Salk Vaccine” for nationwide distribution. Committee members, with the exception of NF members, were oblivious to dangers of the vaccine as discovered by Workman and Eddy and the small numbers of NIH officials to whom they had communicated the presence of “live” virus in the “dead” Salk virus vaccine.

Oveta Culp Hobby, Secretary of the U.S. Department of Health, Education and Welfare, signed the licenses granting permission for five pharmaceutical companies to manufacture and distribute the Salk polio vaccine. As reported by Offit, over the next two weeks, forty lots of the vaccine containing about five million doses would be distributed to public health facilities across the nation by the Cutter Labs, Eli Lilly, Parke-Davis, Wyeth Labs, and Pitman-Moore.[34]

But which “Salk Vaccine” did the Public Health Service Advisory Committee believe it was approving and distributing? The 1954 vaccine used in the earlier field trial or the new reformulated Salk vaccine of 1955?

The question is not rhetorical since, as Dr. Ratner pointed out the “Salk Vaccine” was not one product, but a series of different vaccine preparations made on the same basic principle.[35]

Of course, we know the answer now. It was Salk’s newly formulated, never fully tested, vaccine.

The Timetable for the 1955 Salk Vaccine

Unfortunately, the timetable for the reformulation of the Salk vaccine, even today, is still shrouded in mystery.

First, we don’t know how or when Salk first learned that his 1954 Merthiolate polio vaccine was not effective or potent against paralytic polio due to the alleged interference of Merthiolate, thus necessitating an immediate and drastic reformulation of his 1954 “vaccine recipe.”

Presumably, Salk would have begun his reformulation experimentation sometime between the end of the April 1954 field trial using the Merthiolate Salk vaccine, and November of 1954, when Salk formally notified the NF’s Vaccine and Immunization Committee of problems in his original vaccine “recipe” due to the Merthiolate. He said that the addition of Merthiolate was added against his wishes, at the insistence of the U.S. Laboratory of Biological Control (LBC) as a precaution against bacterial contamination.

The creation of Salk’s new “reformulated” vaccine, minus Merthiolate, involved a different Formalin inactivation process. Salk, however, continued to use the virulent wild strain of the polio virus – the Mahoney strain – in unknown [unstandardized] amounts.[36]

Thus it was that 1955, “The Year of the Salk Vaccine” became “the most distressing year in the history of twentieth century American medicine.”[37] It was also a year of withholding vital information on the Salk vaccine from physicians, public health officers, and the public.[38]

What follows are the details of the massive cover-up by government officials and NF officials that followed in the wake of the first “Cutter Lab” deaths, which were, in fact, “Salk vaccine” deaths.

________________________________

[1] Salk believed the future of polio vaccine research lay in the development of a killed virus preparation even though it was known early on that polio is one of the most difficult viruses to inactivate with formalin . Unlike the live vaccine which contained living polio organisms, the killed vaccine contained dead or inactivated, non-infectious viruses which did not multiply, but which were nevertheless capable of producing antigens to stimulate the production of antibodies which would offer protection from the disease. Thus, immunity could be achieved without infection. In the past, the great obstacle to the development of any killed vaccine had proven to be the difficulty, if not impossibility, of producing a product that was completely free of live viruses (i.e., safe), yet still potent (i.e., effective). Because, if even a small residue of the virulent strains used in the preparation of the vaccine remained, the vaccinated person would then become a walking time bomb; that is, he would become a source of infection to household and community contacts. Further, there were difficulties related to achieving potency and long-term immunity, as well as finding a single killed vaccine that was effective against all three strains (types) of polio. On the other hand, Salk and a number of his colleagues believed the future of polio vaccine research lay in the development of a killed virus preparation. Unlike the live vaccine which contained living polio organisms, the killed vaccine contained dead or inactivated, non-infectious viruses which did not multiply, but which were nevertheless capable of producing antigens to stimulate the production of antibodies which would offer protection from the disease. Thus, immunity could be achieved without infection.

According to Dr. Harold Cox, the quantitative requirements for an effective killed polio virus vaccine produced by existing tissue culture methods at the time was known as early as 1934.Cox stated the principle that you have to have at least 100 million particles per dose for an effective killed vaccine – the exception being the Rocky Mountain spotted fever vaccine. The Salk vaccine never achieved this number of particles.

[2] Sabin and the majority of his colleagues opposed the Salk vaccine. Sabin favored the “live” vaccine that mimicked nature more closely by introducing a mild form of the disease into the environment where people pick it up and then develop an immunity to more virulent forms. This approach followed the lines of the classic principles of immunology by provoking an infection with a harmless strain of the virus to prepare the body for an attack by a more virulent strain. The case for the development of a live polio vaccine for humans was bolstered by experience gained from veterinary medicine where researchers had found living viral vaccines to be superior, cost less, and were easier to administer.

[3] Offit, p.31.

[4] There are two basic patterns of polio infection. There is a minor illness which does not involve the central nervous system (CNS), sometimes called abortive poliomyelitis, and a major illness involving the CNS, which may be paralytic or nonparalytic. In most people with a normal immune system, a poliovirus infection is asymptomatic. The virus enters the central nervous system in about 1 percent of infections. About one to five in 1000 cases progress to paralytic disease, in which the muscles become weak, floppy and poorly controlled, and, finally, completely paralyzed; this condition is known as acute flaccid paralysis.

[5] Offit, p. 34

[6] Ibid.

[7] Ratner, Child and Family. Vol. 19, No.4, p. 274.

[8] Ibid.

[9] Salk used a one paragraph consent form which reads: “I have been informed that Dr. Jonas E. Salk ...with the financial support of the National Foundation for Infantile Paralysis, Inc., has inaugurated in the D. T. Watson Home ... a project for test purposes in connection with a study of infantile paralysis, its causes, remedies, and prevention.... It is proposed to inject into children a poliomyelitis vaccine that has previously been injected into animals without subsequent harm.... To assist in this project I hereby consent that the preparations above mentioned may be injected into my child.” See http://historynewsnetwork.org/article/159990. Informed consents means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

[10] Offit, pp. 35-36.

[11] Ibid., p. 36.

[12] On October 9, 1958, Dr. Melnick submitted a report to the National Foundation/March of Dimes titled Epidemic Poliomyelitis Among Vaccinated Children in Israel. Melnick documented the severe type 1 poliovirus epidemic that occurred among multi-vaccinated Israeli children injected with the Salk vaccine. The NF kept the report “restricted” and “” and it never saw the light of day.

[13] Offit, 45.

[14] Ibid., p. 41

[15] Ibid.

[16] See Child and Family, Vol 19, NO. 4., p. 274. In November 1953, Milzer stated that although his laboratory very rigidly followed the conditions of formalin inactivation as outlined by Salk, the staff were not consistently completely inactivating the virus with formalin. He advised caution so that the tragic consequences that have accompanied poliomyelitis vaccine research in the past not be repeated.

[17] Offit, p.43.

[18] Ratner, Child and Family, Vol. 19, No. 4, p. 274.

[19] Offit, p. 48.

[20] Ibid.

[21] Offit, pp.48-49.

[22] Ibid., 49.

[23] Ibid.

[24] Ibid

[25] Ibid., p. 53.

[26] NIH Director Sebrell is reported to have simply ignored Eddy’s warnings in the summer of 1954, and did not report her findings to the U.S. government’s Vaccine Licensing Advisory Committee. It beggars belief, however, that Sebrell would not have, prior to the start of the national campaign, informed Basil O’Connor at the NF/MOD and/or Dr. Jonas Salk directly, that some Cutter batches (and possibly other manufacture’s products) currently being tested at the LBC for the national campaign were contaminated with live, unattenuated polio virus and were dangerous.

[27] “Bernice Eddy, PhD (1903-1989) Alliance for Human Research Protection,” September 27, 2014, at Bernice Eddy, PhD (1903–1989) – Alliance for Human Research Protection (ahrp.org).Note that Dr. Ratner learned of Eddy’s discovery in 1960.

[28] Details on the Simian Virus 40 are found in Child and Family, Vol. 20, No. 2, pp. 134-138.

[29] See statistician Dr. Bernard Greenberg’s presentation in Child and Family, Vol. 19, No. 3, pp. 199-205. Dr. Greenberg had also testified before the Subcommittee of the U.S. House Committee on Interstate and Foreign Commerce in June 1955.

[30] Evaluation of the Field Trial of Poliomyelitis Vaccine, Final Report. Poliomyelitis Vaccine Evaluation Center, Dept. Epidem., Sch. Publ. Hlth., Univ. Mich., Ann Arbor, April 1957, pp. 1-563.

[31] Howard Markel, M.D., Ph.D, “April 12, 1955 — Tommy Francis and the Salk Vaccine,” New England Journal of Medicine, April 7, 2005, p. 1409. Dr. Markel is associated with the U .of Michigan Medical School at Ann Arbor.

[32] Ibid.

[33] Ibid., p. 52.

[34] Ibid., p. 65.

[35] Ratner, “The Devil’s Advocate and the Salk Vaccine Program: 1955,” Child and Family, Vol. 20, No.2, p.140. Here, Ratner was simply restating what Dr. Francis had himself [36]

[36] In September 1956, New York State Health Department investigators reported that there was a 600-fold variation in the potency of the commercial Salk vaccine on the market.

[37] Ratner, Vol. 20, No.1, p. 50.

[38] Ibid.