Pox (34 page)

On April 4, 1902, a bill was introduced simultaneously in the U.S. House and Senate, sponsored by the Medical Society of the District of Columbia, to create a new regime of federal regulation of biologics. The commissioners of the District drafted the bill, which received a strong endorsement from the District's health officer, William C. Woodward. The District was not home to a single biologics manufacturer. But Woodward noted that there was “no legal reason why any person whosoever should not enter into the business at any time.” In the nation's capital, as in most American states, no restrictions at all governed the production and traffic in biologics. Woodward explained that the “manner in which these substances are produced and marketed” made it impossible to efficiently control them by inspecting only the finished product. The nature of biologics production justified a more intrusive system of licensing and unannounced inspections of manufacturers.
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As if anyone needed reminding, Dr. George M. Kober, chairman of the D.C. Medical Society, advised Congress of the moral urgency of the biologics bill and its connection to the “unfortunate accidents” in St. Louis and Camden that had brought so much discredit upon antitoxin and vaccine. The social value of these lifesaving products—and the considerable risks that attended their manufacture and sale—demanded “that action be taken to preserve the confidence of the medical profession and of the community generally in them.” Like Woodward, Kober expressed dismay at the low barriers to entry in this industry of vital national importance: “Any kind of a stable, a little technical skill, and a fair amount of nerve are all that is needed.” Individual states were “powerless to protect themselves against impure and impotent materials,” especially since most of them consumed biologics made out-of-state. Testing a vial here or a package there was not enough; the whole industry required continuous government surveillance. “For these reasons Federal supervision is necessary,” Kober declared. The House and Senate committees on the District of Columbia went to work on the bill.
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M
emories of a city and its nine lost schoolchildren lingered in the air of the vaccine debate. The report of the Camden Board of Health had not sat well with everyone. Many Americans refused to accept that the vaccine makers were blameless or that public health officials understood the risks of vaccination better than they. Conscientious physicians entertained doubts about the purity of the vaccine in their hands, and considered the possibility, however remote, that they might infect a patient with tetanus. Even some leading vaccine makers found the circumstantial evidence difficult to dismiss. “I am inclined to believe that the New Jersey cases were due to after infection and that the vaccine was not at fault,” confided Ralph Walsh of the National Vaccine Establishment in a private letter, “yet the fact that the cases in Philadelphia, Camden and Atlantic City occurred almost simultaneously and from vaccine propagated by the same party staggers me.”
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Ultimately, the Mulford Company's complicity in the deaths of the nine Camden children (not to mention scattered other fatalities) was a scientific question. As men of science, Robert Willson and Joseph McFarland determined not to let that question go unanswered. On April 23, 1902, as the two congressional committees considered the biologics bill, the Philadelphia County Medical Society assembled to hear Willson and McFarland present their findings.

Dr. Willson spoke first, taking up the gauntlet Dr. McFarland had thrown at his feet back in November. Since then, Willson had prepared abstracts on fifty-two cases of postvaccinal tetanus, which he had found in the medical literature and through personal correspondence with physicians and health officials. The cases dated as far back as 1839, but the majority of them were in children who had fallen ill between October 1, 1901, and March 30, 1902. Willson had discerned, as well as he was able, the circumstances surrounding the production of the vaccine used in each case, as well as the method of vaccination and the care of the wound. Laboratory tests had never detected evidence of tetanus in vaccine virus. And most physicians now understood the importance of following the best aseptic practices during vaccination. That left the patients. Mulling over his abstracts, Willson observed that in almost every case there had been “some gross breach in the care of the wound.” For Willson, the evidence pointing to secondary infections was too strong to dismiss. As he reminded his audience, the streets of American cities were blanketed with tetanus bacilli. The Camden outbreak was unique: there had never been such a cluster of well-marked cases implicating a single maker of vaccine. But Willson concluded this was nothing more than a coincidence. “That vaccine virus may be infected with tetanus no one will deny,” he conceded. “But that it has been, and in such cases as here come to view, deserves the full denial that has been given by the clinical symptoms and a careful scientific study.”
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Joseph McFarland took the floor. Dr. McFarland was anything but a disinterested party. The highly regarded scientist had built the Mulford Company's biologics department back in the 1890s, though his work was primarily in antitoxins, not vaccine. He had left Mulford for a position as professor of pathology and bacteriology at the Medico-Chirurgical College of Philadelphia. McFarland had also been employed, since early 1901, as a consultant for Parke, Davis, Mulford's greatest rival. McFarland's conflict of interest was apparent (Mulford executives certainly thought so). But in the cozy medical world of turn-of-the-century Philadelphia, his position did not discredit his investigation, any more than had the Camden Board of Health's decision to place its investigation in the hands of Mulford's man Albert Barnes. And who in McFarland's audience could resist the chance to hear his paper? It remains to this day a pioneering study in the epidemiology of a pharmaceutical disaster. The quality of the paper is indicated by the fact that it was republished, with only a few significant changes, in
The Lancet
, the preeminent British medical journal of the era and an unwavering advocate of vaccination.
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McFarland spoke as a friend of vaccination, not a critic. Since the first reports of postvaccination tetanus from Cleveland and Camden, he had recognized in this complication “a matter of the gravest importance”—not only because tetanus increased the risk of vaccination but because it aroused “the animosity of those who have banded themselves together for organized opposition against this well recognized and only safeguard against smallpox.” (In the
Lancet
version, the doctor would insert the words “misguided persons” after “those.”) Nor was McFarland above the class prejudices of his peers. Though many Camden parents were still in mourning, he casually observed that the deceased had been “ignorant and filthy children.”
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Like Willson, McFarland had spent the past few months tracking down American cases of postvaccination tetanus. He had found just fifteen in the medical literature, dating back to the 1850s. All had been attributed to secondary infection of the wound. Through correspondence with physicians and health officials, McFarland had turned up eighty more cases, for a total of ninety-five. (Had McFarland access to modern newspaper search engines, he would have found still more.) The first significant fact about these cases, McFarland said, was that sixty-three of them had occurred in a single year, 1901. Most of those had occurred in a single month, November. “Some exceptional condition,” McFarland observed, had “changed an unimportant and infrequent complication into a very important and frequent one.”
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The scientist proceeded to consider, in turn, each of the conventional explanations for the occurrence of tetanus after vaccination. To the argument (espoused by Willson and the Camden Board of Health) that tetanus was an “accidental secondary infection of the vaccination sore,” McFarland conceded that such cases might occasionally occur. But “to content one's self with such a simple explanation may be to fall into egregious error, for if tetanus can thus occur it should do so in all parts of the world, with more or less regularity.” According to McFarland's correspondence with the Imperial Health Office in Berlin and the Pasteur Institute at Paris, the complication was unknown in either Germany or France. Evidently the complication was “chiefly American” and had only become important within a single year.
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McFarland had still less patience for the argument, made by the board of health, that the Camden epidemic was caused by “atmospheric and telluric conditions.” If tetanus were simply “in the air,” Camden and the other afflicted areas should have been plagued by more than the usual incidence of ordinary traumatic tetanus. Instead, the board of health reports of both Camden and Philadelphia showed
fewer
tetanus cases than usual in 1901 (not counting the vaccination-related cases).

To the argument that secondary infections were caused by careless treatment of the vaccination wound, McFarland again raised the question, But why now? Vaccination had been practiced for more than a hundred years, for most of that time “with a total disregard to cleanliness and asepsis.” Why was the complication so prevalent now—decades after Koch and Pasteur—when vaccination was practiced with greater aseptic precautions than ever? And why was postvaccination tetanus epidemic only among Americans, rather than, say, among “the densely ignorant and filthy people of the island of Puerto Rico,” where the Army had performed 860,000 vaccinations in 1899, with only two or three cases of tetanus reported?
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McFarland proceeded to the tougher part of his argument: to show that tetanus must have been present in the vaccine itself. The Camden health board investigators had tested samples of the locally available makes of vaccine and had found no evidence of tetanus in any of them. McFarland, who had made his name in the laboratory, did not present fresh laboratory evidence. What he did offer was evidence, gathered presumably from his correspondents, as to precisely which vaccines had been used in the ill-fated procedures. The rumors had been right. The “great majority of the cases” in 1901—thirty out of the forty cases that he was able to document—had followed the use of a single make of virus. Cleveland, Camden, Atlantic City, Philadelphia—in every locale, the closely clustered cases implicated “chiefly if not exclusively” one vaccine. McFarland named no names (he labeled the offending vaccine “virus E”), but as everyone in that room knew (and as McFarland's personal papers confirm), the maker was his former employer, Mulford. McFarland was ready to stipulate that “no care or expense” had been spared to produce these products. But the evidence, he said, “leads me to conclude that tetanus bacilli may be contained in the virus and distributed with it.” In the
Lancet
version, McFarland would strike that “may be” and write “is.”
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McFarland's most powerful piece of evidence—also epidemiological, rather than bacteriological—came from the Philadelphia Hospital. Small-pox had broken out among the hospital's 4,500 “inmates.” Physicians went through the hospital vaccinating everyone, the sick and the well, with the exception of one section, the Men's Insane Department. The inmates of that department “were obliged to wait until a new consignment of the virus arrived.” The new consignment was “virus E.” All of the men were vaccinated. Now, McFarland had done some digging in the hospital records. Not a single case of spontaneous traumatic tetanus had occurred in the Insane Department for at least twelve years. As vaccination proceeded, though, five men in the department developed tetanus. All of them died. The outbreak caused a great deal of alarm in the hospital, and afterward, the doctors took additional precautions in dealing with suspicious vaccination wounds. Eleven more men fell ill with tetanus; after receiving “enormous doses of antitoxin,” all recovered. With one possible exception, every patient who developed tetanus had been vaccinated with “virus E.” At this moment, McFarland must have looked out at his audience. “There is something about virus E,” he said.
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As to how the vaccine of one of the nation's most reputable and scientific makers might have been so terribly corrupted, McFarland invoked the world of the biologics stables that he knew so well: the manure of the calves, the hay, the dusts. . . . Glycerin seemed powerless before tetanus, as the cases implicated all of Mulford's vaccine products: dry points (unglycerinated), glycerinated points, and glycerinated lymph. (Later that year, Milton Rosenau would report that glycerin
preserved
tetanus spores.)
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Good scientist that he was, McFarland conceded to his audience that his argument had a “sole weakness.” And that was the incubation period. Tetanus usually set in within ten days after an injury. Everyone cited William Osler's standard medical treatise on this point; McFarland had studied under the man at the University of Pennsylvania. In the vaccination cases, though, the average time elapsed between the procedure and the onset of tetanus was twenty-two days. But McFarland had a theory. He suggested that while the tetanus bacilli had been “ingrafted into the skin at the time of vaccination,” they did not start to grow until “the development of the vaccine lesion pave[d] the way by the local destruction of tissue.” This hypothesis would add about two weeks to the usual incubation period, for a total duration of about three weeks.
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We may never know for certain what caused the deadly outbreaks of postvaccination tetanus in Camden and other American communities in the fall of 1901. McFarland put forth compelling evidence to implicate Mulford's vaccine, but the argument's weak point—the incubation period—does leave a remainder of doubt. Still, there is no mistaking the political repercussions of these events. The vaccine crisis that erupted at Camden shocked the nation, roused the medical profession, and, ten weeks after Willson and McFarland presented their findings, ushered in a major change in American political institutions: the creation of the first effective system for regulating the production and sale of biologics.