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Don't Rush To Hand Out the Ebola Vaccine

In 1934 and 1935, two polio vaccines were prematurely employed in large-scale trials with disastrous results. The vaccines, given to 17,000 children in Canada and the U.S., killed six and paralyzed a dozen others, the deaths and paralyses typically involving paralysis in the inoculated arm rather than in the legs, as was more normal. So traumatic was this experience -- to both the public and the research establishment -- that it would take another two decades before another polio vaccine would be brought to market.
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An Ebola vaccine that protected us from this killer disease would be a godsend. But rushing a vaccine to widespread use, history has shown, could be tragic, not only by infecting the healthy but also by delaying the development of safe and effective vaccines.

In 1934 and 1935, two polio vaccines were prematurely employed in large-scale trials with disastrous results. The vaccines, given to 17,000 children in Canada and the U.S., killed six and paralyzed a dozen others, the deaths and paralyses typically involving paralysis in the inoculated arm rather than in the legs, as was more normal. So traumatic was this experience -- to both the public and the research establishment -- that it would take another two decades before another polio vaccine would be brought to market.

Tragically, the 1955 vaccine -- named after its inventor, Jonas Salk -- had an even more disastrous debut. In the rush to mass-produce this vaccine amid the polio outbreaks of the early 1950s -- this vaccine received the quickest federal approval on record -- caution was thrown to the winds, with Salk and the head of the National Institute of Health refusing to heed warnings, including from other scientists in the field and from a scientist within the NIH itself. The result: 70,000 afflicted by the polio vaccine, 51 of them left permanently paralyzed, plus five deaths. These afflictions were then followed by an epidemic among the family and friends that these vaccine recipients came into contact with, with a further 113 paralyses plus five deaths.

The polio inoculation program was then in chaos. The U.S. suspended its program less than a month after the first child was vaccinated; the U.K. and Germany abandoned their planned campaigns; Sweden called off production of its own homegrown vaccine. The Salk vaccine, though the problems that led to the disaster were soon corrected, would be displaced by the Sabin vaccine -- ironically now viewed as having been more dangerous than the Salk vaccine. Because of the Salk vaccine's monumental failure, Salk never received the Nobel Prize and the NIH was censured by a Congressional committee.

The public also turned against the vaccine and public authorities, the lack of demand leading some drug companies to halt production in 1958. But the public eventually embraced the improved polio vaccines -- polio was its #2 fear in the 1950s, next to the atomic bomb, and it reluctantly accepted assurances that the risk of taking the improved vaccine was lower than the risk of contracting polio naturally.

Government panic and politics during a presidential campaign created another fiasco in 1976, after a 19-year-old soldier at Fort Dix, New Jersey, came down with what was dubbed "swine flu." Raising the spectre of the 1918 Spanish Flu that killed an estimated 20 million to 40 million worldwide, President Gerald Ford launched his National Influenza Immunization Program later that same year, with Canada following suit within days. Although its goal was the inoculation of every man, woman and child, the program was scrapped after just two months, following numerous reports of adverse reactions, including paralyses and deaths. Another casualty was public confidence in health authorities and in vaccines.

Inadequate early testing has led to other vaccine failures. The first few measles vaccines had to be taken off the market due to numerous adverse reactions, including deaths. Four years ago, a flu vaccine that harmed 5% of the children who received it in Australia and New Zealand, was taken off the market before disaster could affect us (our flu season follows theirs). Two years ago, 14 children in Argentina died in trials for a pneumonia vaccine by the British firm, GlaxoSmithKline.

Mistakes in novel areas of science inevitably happen, and especially in highly politicized periods where public panic can run high and governments are under the gun. Harper's Magazine, in an August 1955 article entitled "Who is responsible, and why, for the chaotic confusion over the polio inoculations?" had this to say about what many now consider the greatest public health failure in history:

"The Great Vaccine Mess was a tangled compound of many factors. It involved technical questions so abstruse there are scarcely two score men in the United States competent to pass on them, and everyone with a direct part in the situation, or nearly everyone, acted from the best of motives.

"But demagogy and political expediency also contributed to the brew. So did over sensationalism by the press, radio, and TV, and a misguided attempt by the Department of Health, Education, and Welfare to withhold from the public for many weeks information the public was entitled to have from the beginning. Also involved were timidity and lack of leadership; a complete failure to educate the public properly on vaccines (despite all the propaganda); the constitutional unwillingness of scientists to give absolute guarantees; and many things more."

Harper's analysis eerily resembles the mix of scientific and political issues that are now developing over the Ebola vaccine. Let history not repeat itself.

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