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n July 1, 1902, President Theodore Roosevelt signed the bill now known as the Biologics Control Act. Drafted by the District of Columbia Medical Society, the bill had been introduced by the Republican senator John Coit Spooner of Wisconsin. Although born of a great public controversy, the bill itself seems to have provoked little. Spooner's papers contain little correspondence regarding the legislation, and both houses of Congress enacted it without debate. As
The New York Times
noted, “The bill . . . would involve a dangerous expansion of Federal authority were it not aimed to correct an evil yet more dangerous as directly and immediately affecting the public health.” The case for government regulation, the
Times
observed, “has been emphasized by recent experiences with virus and serums charged with tetanus germs and pus organisms.”
91
Although the law originated in the District, its provisions reached the nation. Effective January 1, 1903, the law established a system of licensing and inspection for all biologics sold in interstate commerce or imported from abroad. Practically speaking, this meant that all substantial makers of vaccines, antitoxins, serums, and toxins in the United States would need to seek a federal license to continue to trade in biologics. The act empowered a federal boardâcomposed of the surgeon generals of the Army, Navy, and Marine-Hospital Serviceâto promulgate regulations to be enforced by the Treasury Department. Unannounced inspections would be carried out at the discretion of the treasury secretary. The act also required manufacturers to plainly label each product with the maker's address and license number and the date “beyond which the contents cannot be expected beyond reasonable doubt to yield their specific results.” Penalties included suspension of the license, a maximum fine of $500, and up to one year's imprisonment.
92
On the same day, Congress passed another law that enlarged the authority of the Marine-Hospital Service and gave it a commensurately bigger name: the U.S. Public Health and Marine-Hospital Service. Service medical officers would serve as the frontline inspectors of the new biologics licensing regime, and Milton Rosenau's Hygienic Laboratory would administer the act. The federal biologics board promulgated its first regulations in February 1903; they became effective that August. To receive a license, makers had to submit to an inspection by a medical officer from the Service. Licenses were good for just one year and could be reissued only after another inspection. If an inspector turned up any problemsâbad production standards, impure or impotent productsâthe government could suspend a maker's license for thirty days; if the maker did not correct the problem, the government could revoke its license. Parke, Davis received license no. 1; H. K. Mulford no. 2; and H. M. Alexander no. 3. By 1904, the government had inspected and licensed thirteen biologics establishments, mostly for the manufacture and sale of diphtheria antitoxin and smallpox vaccine. Forty-one companies would hold licenses by 1921; all told, those companies marketed more than a hundred different biological products.
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The new law had an immediate impact on the biologics industry. The government refused to license some shoddy makers and suspended the licenses of others. Some smaller companies simply shut down, knowing they could not afford to meet the new standards. In the first few years of the new regime, Mulford's Pennsylvania rival H. M. Alexander had its license suspended and was twice ordered to remove tainted products from the market. In 1908 and 1909, Mulford and Parke, Davis had their licenses suspended when hoof and mouth disease broke out among their antitoxin horses and vaccine cows. Rosenau's Hygienic Laboratory continued his old practice of secretly buying up biologics on the open market and testing them for potency and purity. Vaccine quality in the United States rose dramatically. Between 1902 and 1915, laboratory staff routinely tested smallpox vaccine for tetanus bacilli; none were found. The Hygienic Laboratory grew apace with its new responsibilities and powers. From Milton Rosenau's one-man operation in 1902, by 1904, the laboratory had a staff of thirteen, and it would continue to grow. In 1930, the Laboratory would be given a new name: the National Institute (later Institutes) of Health.
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The vaccine crisis of 1901â2 also prompted local and state health boards to increase their interventions in the vaccine market. In 1903, the Massachusetts legislature authorized the state board of health to manufacture its own lymph and antitoxin under the supervision of Theobald Smith. “Having provided for compulsory vaccination in this state,”
The Boston Globe
commented, “the authorities are at least bound to see to it that the humblest citizen is provided with as perfect vaccine as it is possible to secure.” Other state and local boardsâincluding Cleveland'sâregularly inspected vaccine lots in their own bacteriological laboratories.
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Leading biologics makers, particularly the largest firms, welcomed the new regime. The new system defused the vaccine crisis and gradually strengthened public confidence in vaccine and antitoxin. The new regulatory system, like other progressive business regulations instituted during the early twentieth century, fostered corporate consolidation by driving many small competitors out of the industry altogether (a welcome benefit to the likes of Parke, Davis and Mulford). Government licensing conferred a federal stamp of approval upon commercial vaccines, and the law established the government as a cooperative partner rather than a rival manufacturer (or, worse, a monopolistic one) in the brave new world of biologics. The National Hygienic Laboratory shared its research with private firms, ultimately saving those firms a great deal of money. The revolving door between government, academia, and the pharmaceutical industry continued to spin, as Joseph J. Kinyoun, Rosenau's predecessor at the Hygienic Laboratory, left the government in 1903 for a position as director of the Mulford laboratories in Glenolden. Rosenau himself would leave the laboratory six years later for a position at Harvard.
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Over time, all of this government activity increased the quality of American-made vaccines (not to mention other biologics) and assured the physicians and the public that they were not being compelled to undertake unnecessary risks in the name of the public health. The public would accept that assurance only gradually, and never fully. Four years after the passage of the Biologics Control Act, Congress would enact another, much better remembered statute modeled closely after it, the Pure Food and Drug Act. Together, the two laws introduced an unprecedented level of federal regulatory authority over one of the most profitable areas of American commerce and manufacturing, the pharmaceutical industry.
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The Biologics Control Act resolved one of the greatest contradictions in the practice of the nation's burgeoning public health systems: compulsory vaccination of the people without any governmental review of product safety. The new inspection regime saved compulsory vaccination at its moment of greatest crisis in the United States. Testifying before a House committee in 1910, Dr. C. T. Sowers of Washington, D.C., recalled the days, before the Biologics Control Act of 1902, when anyone who had a few cows could start up a vaccine farm. “There was no government inspection at that time of these farms, and the consequence was a very impure product,” he said. “For us to have enforced vaccination before government inspection I have always regarded as extremely wrong, but now we can do it with the utmost propriety in stopping epidemics of smallpox.”
98
It is possible that Dr. Sowers had always regarded the old arrangements as fundamentally unjust. Or maybe he, like most doctors and public health officials, only came to appreciate that injusticeâand its political untenabilityâafter nine children died at Camden and the parents of that city, echoed by the protests of ordinary Americans in communities across the country, demanded a new dispensation of coercion and risk in American law.
For Camden, the new era arrived too late. The tetanus outbreak of November and December 1901 had sharpened public fears of that mysterious product of the stable and the laboratory called vaccine. So many parents revolted against vaccination that school officials delayed reopening the schools after Christmas break. Many residents continued through the winter to tell their doctors that they viewed vaccination as an unacceptable health risk for them and their children. They preferred to take their chances with smallpox, rather than risk exposing their loved ones to tetanus.
No more postvaccination tetanus deaths occurred in Camden after Bessie Rosevelt's death in December. But the toll from smallpox rose. By March 1902, smallpox had struck 165 people in the city, killing 15. Few among the dead in Camden had ever been vaccinatedânone of them within the past three years. By the time the epidemic wound down that spring, smallpox had indeed proved more fatal there than vaccination.
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SIX
THE POLITICS OF TIGHT SPACES
In the rear room above Caballo's saloon in East Harlem, behind the door with the big brass padlock, three children lay sleeping one cold February night in 1901. They slept under the bed, on a piece of cloth. Molina Caballo, the eldest, was four. Huddled beside her were her baby sister, Rose, and eighteen-month-old Antoinette Alvena. Some boxes of clothing stood by the bed, like a low wall, blocking the view from the doorway.
1
Out on the street two hundred and fifty men awaited the order to move. Their breath formed a bank of fog against the winter night. Half of them were doctorsâvaccinators and inspectors from the New York City Department of Health. The rest were uniformed patrolmen from the East 104th Street Police Station. It was 9:30, the hour chosen by Dr. Alonzo Blauvelt to ensure that the working people of Italian Harlem would be at home in their beds. The forty-seven-year-old chief inspector of the department's Division of Contagious Diseases had forsaken the warmth of his own bed to lead this raid in person. The vaccination corps aimed to inspect every room, yard, and body between Second Avenue and the East River, moving north from 106th Street to 115th Street. On an ordinary street map, the area didn't look like much: a few blocks on a vast city grid. But to the Department of Health, this stretch of five- and six-story tenements, where as many as five large families crowded onto every floor, marked a trouble spot in the medical geography of Manhattan, one of the island's most thickly populated and disease-ridden Italian “colonies.”
2
Ten weeks had passed since the Thanksgiving smallpox outbreak on All Nations Block, over on the West Side. In that time, the department had reported nearly two hundred casesânot quite enough to strike terror into a city of three and a half million people, but more than enough to cause the circulation of library books to plummet, the city's regional trade to shrink, affluent families on the Upper West Side to cast out their servants, and the health department to hire seventy-five extra vaccinators. The department's smallpox strategy, as Blauvelt had recently explained it to
The New York Times
, involved isolation of all infected persons, surveillance of their family members and known contacts, and vaccination of “suspicious neighborhoods.”
3
City health officials often reminded the public that the Empire State had no compulsory vaccination law. But their actions said otherwise. The department's strategy for containing smallpox ensured that the full power of public health policing would be felt chiefly in the city's tight spacesâthe crowded places where the wage earners lived, worked, prayed, and amused themselves. In those places, made closer still by the sudden entry of a vaccination squad and its armed police entourage, the department's authority proved hard to resistâand yet hard
not
to. What counts as compulsion is a question best answered by the person with her back to the wall. Even Blauvelt had said, after the December raids of the Bowery lodging houses, where his men had vaccinated 4,500 homeless people, that the sight of all those nightsticks “might have been something of a persuader.”
4
The response of American public health departments to epidemic smallpox at the turn of the century revealed progressive social governance at its most powerful and problematic. New York City's methods were exceptional only in their bureaucratic sophistication and scale. The same working principles, tactics, and values drove campaigns against smallpox in urban communities from San Francisco to Boston. The known behavior of smallpoxâits tendency to spread like wildfire in crowded placesâdictated a spatial response. In fact, smallpox would one day be eradicated across the world using a strategy of isolation, surveillance, and targeted vaccination not so different from that used by New York City to fight this, its last major epidemic of the disease, in 1901 and 1902. But the spatial strategy of disease control generated its own political theater of government coercion and working-class resistance.
Space, a necessary condition for the exercise of human freedom, came at a premium in the modern, urban-industrial society that the United States was so rapidly becoming. No one knew the price of space better than “the masses”: the sort who journeyed to America below the water line, in the teeming steerage compartments of steamships, and who sought work in factories and mines, shelter in tenements and lodging houses, leisure in saloons and dance halls, and an education for their children in the public schools. Fighting contagion in the name of the public health meant wielding extraordinary authority in those tight spaces. Public health was, without question, a cutting-edge, progressive enterpriseâthe marshaling of modern science for the betterment of society. Few stood more to gain than tenement dwellers from successful campaigns against smallpox and other plagues. But as the price for the space they occupied in the nation, such people were expected to bear a level of intrusion and coercion that American governments did not dare ask of their better-off citizens. As a consequence, smallpox control triggered some of the Progressive Era's most dramatic conflicts between working-class people and the government. That is why Blauvelt's medical men traveled with a police escort.