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The vaccine crisis seemed to require a new role for the state in controlling production. But what sort of control? Like their European social-democratic counterparts, progressive reformers in the United States insisted that certain areas of life were too precious to leave entirely to the unregulated market. This call for a sort of decommodification—to replace capitalist price with government discipline—was a common thread running through a great many otherwise disparate reform causes, from the movement for public ownership of streetcars to the campaign to ban child labor. The disasters in St. Louis and Camden convinced many physicians and health officials that vaccine production had been left to the free market for too long. “The lesson we have principally to learn from these catastrophes,” said Dr. Dalton of New York, “is the necessity of eliminating commercialism from matters pertaining to public health.”72
The professional debate centered on two options. The first was for states to manufacture their own vaccines, in effect socializing the industry (as Japan had done in 1896). Eugene A. Darling, director of the Cambridge, Massachusetts, Bacteriological Laboratory, noted the ethical clarity in this approach. He said, “The State compels the child to be vaccinated, and should furnish the lymph for the operation, guaranteed to be pure and efficient.” The other option was to bring commercial vaccine makers under the discipline of a new regime of licensing and inspection. Since vaccines were an interstate business, most supporters of regulation called for the involvement of the federal government. This, too, was a bold idea: the federal government did not regulate drugs or biologics manufactured in the United States. (Since 1848, federal law had banned the importation of adulterated or spurious drugs, but that law did not touch domestic manufactures.) The entire professional debate took place in the context of rising antivaccination sentiment. In early February, the Massachusetts legislature held hearings on a bill to repeal the state’s compulsory vaccination law. The committee heard an emotional appeal from the mother of Annie Caswell, a five-year-old Cambridge girl who had died the previous month from tetanus after vaccination. The bill failed. But that effort and others like it helped keep the vaccine purity question before the press.73
The idea of government production, which American Medicine dismissed as “almost out of the question,” met with powerful opposition from vaccine makers and the druggists who sold their goods. The makers had long enjoyed a cozy relationship with state and local health boards, aggressively seeking their contracts and endorsements. And, of course, every vaccination order created a demand for commercial products. Not surprisingly, the makers did not welcome competition from their longtime sponsors. “A Board has no right to enter into commercial enterprises,” the St. Louis Medical Journal declared in 1898, a few years after the city health department introduced its ill-fated antitoxin. That same year, the New York County Medical Society sponsored a state bill that would have forbidden the Tammany-controlled New York City Health Department to sell its surplus biologics; the bill failed. In 1900 and 1901, manufacturers and druggists urged Congress to stop the Department of Agriculture from providing ranchers with free vaccine for blackleg, a disease of cattle and sheep. At a time when some of America’s more progressive municipal governments were taking steps to provide their citizens with necessary services—including water, electricity, and gas—production of vaccines and antitoxins by local health boards was met with slippery-slope charges of “municipal socialism.” (Bona fide socialists bristled at the association. Socialist Labor Party leader Daniel De Leon countered, “The vaccination laws are capitalist laws: they were framed by capitalist legislatures; they have been passed upon by capitalist courts; they are enforced by capitalist officials. From first to last the spirit of capitalism has dominated the whole procedure.”)74
In the winter of 1901–2, druggists and vaccine manufacturers waged a protracted campaign to beat back government production in the few places it already existed. (The great exceptions were in the new U.S. colonies in Puerto Rico and the Philippines.) On the U.S. mainland, the vaccine interests held up the St. Louis tetanus outbreak as the tragic but inevitable result of placing production in the hands of a political machine. “It is difficult enough to keep politics pure,” said the Minneapolis-based Medical Dial, “but it is impossible to make pure political antitoxin.” Seizing the moment, the makers and druggists pressed Mayor Seth Low of New York to stop the city health department from the “destructively competitive” practice of selling its highly regarded vaccine and antitoxin on the market. Even reformers worried that municipal governments controlled by political machines would produce products more dangerous than those already available on the commercial market. Others insisted there was something un-American about the whole idea. “No government has the right, morally, legally, or commercially to enter into any business for pecuniary profit,” declared the Medical Record. Neither purity of product nor cheapness to consumers could justify it. “A municipal laboratory is not a shop.”75
The so-called Continental method of monopolistic government production was not going to happen in the United States. Government regulation was controversial enough. Here, too, there were European models. In Italy, which had the most extensive system of regulation in Europe, would-be makers of any biologics (including antitoxin and vaccine) had to first secure the consent of the interior minister. (Germany, France, and Russia also had national systems of control covering specific biologics). In the United States, some commentators objected that any such system was impractical and contrary to the American way. “In a country as large as ours, and with our republican form of government,” American Medicine commented, “it would be very difficult, if not impossible, to carry out the supervision suggested.” In the United States a dozen commercial establishments made diphtheria antitoxin. Each had 25 to 250 horses. Was the government really prepared to “test the serums of 100 or more bleedings a day” at sites around the country?76
But by the spring of 1902, it increasingly seemed clear to the medical profession that a national licensing and inspection regime was an idea whose time had come. The events in Camden and St. Louis had made such a move seem inevitable to organized physicians and vaccine makers alike. In late March, the Medical Record described the emerging professional consensus. “Of late, owing chiefly to the accidents which have occurred recently in this country from the use of diphtheria antitoxin and vaccine virus, there has been a movement in favor of Government control of such products,” the journal said. “This proposition is not only highly proper under present circumstances, but absolutely imperative.” But regulation was as far as this journal, or the profession, was ready to go. Government competition with free enterprise was unacceptable. Much the same conclusion was reached in an informal discussion at the annual meeting of the American Medical Association that spring. The old arrangement in American public health law—which allowed compulsory vaccination with unregulated products—was no longer tenable. A resolution introduced to the Homeopathic Medical Society of New York caught the spirit of many others: “when the State or local authorities enforce vaccination they are in justice bound to surround it with all the modern safeguards.”77
There were a few precedents for such state-level regulation. In the most ambitious effort, Pitfield’s grand tour of American vaccine farms for the Pennsylvania board in 1896 had demonstrated just how revealing on-site inspections could be. But the power of a state health board only reached so far; it could only use such information to control vaccine sold or produced within the state. The vaccine business was an interstate trade; the larger firms like Parke, Davis even manufactured and marketed their wares beyond the nation’s borders. An effective system of government regulation, many reform-minded physicians concluded, would have to be a federal government responsibility. Rosenau’s study of the vaccine market had shown the potential of that idea; in fact, Rosenau did not conceal his belief that the Marine-Hospital Service (with his laboratory) was the natural agency for the job.
On April 4, 1902, a bill was introd
uced 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.78
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.79
Memories 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.”80
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.”81
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.82
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.”83
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.”84
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.85
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?86
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.”87