The CDC met on July 27 with the National Hemophilia Foundation, the American Red Cross, and the FDA, and mutually agreed to an aggressive surveillance effort.
By December all three of the original hemophilia/AIDS patients were dead.
Yes, AIDS.
In August the CDC had quietly dropped the term GRID, changing the name of the disease to Acquired Immune Deficiency Syndrome to reflect the recognition that it wasn’t just a disease of gay men.
Five more Americans with hemophilia contracted AIDS in 1982, one of them a seven-year-old boy. And in the fall of 1982 Curran’s team got word that Dr. Arthur Ammann, a pediatrician with the University of California at San Francisco Medical Center, was treating a baby with PCP. The twenty-month-old patient had received multiple transfusions at birth.
AIDS was in the U.S. blood supply. The CDC ended their report with the following statements:
Of the 788 definite AIDS cases among adults reported thus far [December 10, 1982] to CDC, 42 (5.3%) belong to no known risk group (i.e., they are not known to be homosexually active men, intravenous drug abusers, Haitians, or hemophiliacs). Two cases received blood products within 2 years of the onset of their illnesses and are currently under investigation.
This report and continuing reports of AIDS among persons with hemophilia A raise serious questions about the possible transmission of AIDS through blood and blood products.39
For physicians it was alarming news. At the time most U.S. blood banks and blood factor manufacturers purchased plasma, and the prime “$10 donors,†as they were called (though they might earn $100 per donation), were drug addicts and alcoholics looking for quick cash. New York physician Frederick Siegel immediately called for cessation of blood and plasma purchasing as well as stern advice to gay men that they not donate their blood.
No immediate action followed.
A week after the agency released its blood report, the CDC announced that four other babies and infants definitely had AIDS and eighteen were suffering suspicious immunodeficiencies. None of these children had received blood transfusions, but most had mothers who either had AIDS or fit into an already defined risk group for the disease. Of the thirteen mothers interviewed for the investigation, eight were injecting drug users, one was both a drug user and a prostitute, and two were Haitian. The children all came from areas obviously affected by AIDS: San Francisco, New York, Newark.
“Transmission of an ‘AIDS agent’ from mother to child, either in utero or shortly after birth, could account for the early onset of immunodeficiency in these infants,†the CDC scientists wrote.40
In San Francisco, Mrs. Profit, as she was called, gave birth to two children in 1981–82; both had AIDS. A prostitute who worked San Francisco’s tough Tenderloin district, Mrs. Profit already had an advanced case of AIDS herself when Dritz’s public health team caught up with her in late 1981. By that time Profit was already fairly incoherent, and doctors later concluded that she had AIDS dementia.
Profit wasn’t able to be of much help to Moss, Dritz, and other researchers who quizzed her. Though the white woman worked as a prostitute, Moss concluded it was through her injecting drug habit that she had become infected. Or via her extremely secretive and also AIDS-plagued husband, a heterosexual male who refused to provide the scientists with any information.
As the new year opened, the United States had its one thousandth official case of AIDS, and CDC scientists knew the true numbers were far greater.41
By the end of 1982 the CDC had nailed down every basic aspect of the epidemiology of AIDS save one: identifying the causative microbe. But they knew it was infectious, was in the nation’s blood supply, could be passed by gay men to one another through sexual intercourse, by mothers to their babies, and among drug injectors who shared needles.
And though in this matter the CDC erred, the agency already had evidence of heterosexual transmission of AIDS. All but five of their fifty-five heterosexual cases were improperly given a segregated label as “Haitian.†(A nationality designation did not equal a mode of transmission.) The other five suspected heterosexual cases were women whose steady sexual partners were male injecting drug users.42
Though puzzles remained, the essential epidemiological outlines were in place, and some decisions about public health action could be taken to stop the epidemic’s spread.
Yet a decade later many of the preventive steps that seemed obvious in January 1983 would remain untaken. Delays would be numerous. People would continue to die, and the epidemic would expand.
II
Though microbes know no politics, and Homo sapiens of all ideological stripes could be infected with the agent responsible for AIDS, every aspect of AIDS research, control, and treatment was highly politicized by 1983.
When it came to AIDS, every organization and agency seemed to be breaking its own long-standing protocols vis-à -vis infectious diseases. Municipal public health departments, afraid of offending gay voters or civil libertarians, were reluctant to close down bathhouses, despite clear evidence that many—perhaps most—of the homosexuals diagnosed at that point with AIDS acknowledged having frequented the baths. Bathhouse owners, afraid of scaring off customers, only agreed under legal pressure to post signs warning of the risks that might be associated with casual sex. Gay rights organizations all over the United States split politically over what levels of alarm and action seemed appropriate.
Blood bank administrators gave lip service publicly to concern about blood supply safety, but privately told government authorities that no steps could be taken to ensure product safety without incurring prohibitive costs. And the National Heart, Lung, and Blood Institute told Congress that it had no intention of funding research into the safety of the nation’s blood supply until the end of 1984. No serious survey of the nation’s blood supply would be undertaken until September 20, 1984.43
Throughout the fall of 1982 the National Hemophilia Foundation (NHF) met with blood industry representatives and federal scientists in hopes of finding a way to ensure the safety of products used by its membership. They were repeatedly met with calls for proof, for data linking something in the nation’s blood and plasma supplies to the ailments suffered by people with hemophilia and transfusion recipients. Only the CDC team wholeheartedly supported the NHF’s call for action.
At the behest of the NHF and CDC a meeting was convened in Washington, D.C., on January 4, 1983, with leading blood industry representatives and officials from the Food and Drug Administration to discuss the first handful of transfusion and blood coagulating factor AIDS cases. The CDC’s Bruce Evatt, Curran, and Francis hoped to convince the blood industry to take steps to decrease the possibility of passing on whatever caused AIDS via blood, not only to protect Americans who had hemophilia or were undergoing surgical procedures that required transfusion but also the millions of people internationally who relied on blood products from the United States, the world’s largest blood product exporter.44 Conservative estimates valued the U.S. share of the industry at $150 million a year. Four American companies dominated: Baxter Travenol Laboratories, Inc.; Alpha Therapeutic Corporation; Armour Pharmaceutical Co. (a division of the Revlon Cosmetics corporation); and Cutter Laboratories. The domestic blood market, controlled by diverse for-profit and nonprofit interests, was conservatively estimated to be worth roughly $250 million a year.45
Less conservative estimates of the global blood industry, compiled by the Philadelphia Inquirer Pulitzer Prize-winning journalist Gilbert Gaul, put plasma annual sales revenues at $2 billion, with U.S. companies and blood banks responsible for over 60 percent of worldwide sales of some 6 million liters of plasma every year.46
The use of blood products doubled in the United States between 1971 and 1980, due both to an increase in the number of surgical operations and to perfection of procedures for isolation and preparation of Factors VIII and IX, the coagulants most com
monly needed, for genetic reasons, by people with hemophilia.47 New surgical innovations were putting unprecedented pressure on the blood supply. For example, a transplant procedure might require over 150 units of whole blood for a single patient. In 1980 just over 11 million units of blood were collected in the United States. By 1982 that figure had jumped to 12.6 million, and about 4 million Americans received blood products that year.
All but 2 percent of the nation’s blood supply was voluntarily donated. Plasma was another matter. Donation of plasma was a three-hour procedure, during which the individual’s blood was removed and spun down in a centrifuge to separate the watery plasma from blood cells. The cells were then infused back into the donor’s body. Because it was a demanding, uncomfortable procedure, most of the world’s plasma came from paid “donors,†and the United States bought more plasma in this manner than did any other country in the world. Legally, in the United States, individuals could sell their plasma twice a week, or up to 60 liters a year, which was four times WHO’s recommended maximum for individual “donation.â€
Individuals were typically paid around $25 for donating plasma, and most “donors†were regulars: hard-luck characters who frequently sought quick cash from local hospitals and storefront plasma centers.
With fewer than 240,000 units of whole blood purchased in the United States, and perhaps less than 10 percent, or 24,000, of those units contaminated with any of the dozens of microbes known to be passed among injecting drug users, the odds that any given blood recipient in 1982 could become infected with, for example, hepatitis B, might be calculated to be well below 1:11, 997, 600.48 Since nobody knew what microbe caused AIDS, it wasn’t possible to calculate the odds in 1983 of becoming infected following transfusion with a single unit of blood.
But the clotting factors were proteins found in extremely minute quantities in plasma, and about 5,000 plasma units49 were required to manufacture enough Factor VIII or IX concentrate to stop serious bleeding episodes among people with hemophilia. That upped the ante considerably: the odds of getting hepatitis were probably at least 1:3,000. For people with hemophilia, each Factor injection carried a reasonably high chance of infection with some microbe.
The estimate of 1:3,000 was based on an assumed minute level of contamination among the paid donors. Gay men were no less altruistic in donating blood in 1982 than were their heterosexual counterparts. If one conservatively assumed that 4 percent of all blood donors were gay, and 10 percent of them carried some type of blood-transmissible agent, that could mean up to 47,000 units of the American donated—unpaid—blood supplies were contaminated, or 0.003 percent. Again, a minute risk if one were exposed to only one or two transfused units of blood, but a considerable hazard for people with hemophilia.
Retrospective tests of the blood supply would later show that in 1978 at least one batch of Factor VIII was contaminated with the AIDS agent. It was dispensed to up to 2,300 men and boys with hemophilia that year.50
The risk for people with the genetic blood-clotting disease was compounded by their need for frequent injections, amounting to between 25,000 to 65,000 international units (IU) of the crystallized protein powder per year. An average treatment ampule was equal to 100 IU. Therefore, the typical person with hemophilia was annually exposed to the blood of 1,250,000 to 3,250,000 people. Severe cases of hemophilia could require use of products derived from 13,555,000 units of blood each year. With that level of exposure, even an extraordinarily rare microbe found in only one out of every 3 million Americans could pose a serious threat.51
Widespread, nonemergency use of Factors VIII and IX worldwide did not begin until 1975, when the U.S. Congress created financial incentives for the manufacture and distribution of the product with the passage of the Hemophilia Diagnostic and Treatment Center Program Act. By 1982, 75 percent of all people with hemophilia already had abnormal liver function, due to hepatitis (types A or B) infections, and more than 90 percent of them had been exposed to the virus. Though the blood industry was using a heating technique to eliminate live microbes from blood used in the manufacture of another human protein product, albumin, it did not heat-treat clotting factors. A variety of reasons for this were offered, but they all boiled down to the small size of the hemophilia product market, the added costs of sterilization, and the lack of studies demonstrating its reliability in the case of Factors VIII and IX. In 1980 a single Factor VIII dose cost a patient about $90.
In 1987, after heat treatment and other blood safety techniques were common practice, that same dose of Factor VIII would cost more than $1,000. By 1989 hemophilia patients would, on average, spend over $50,000 per year. Despite the more than tenfold increase in costs, the industry would remain quite healthy, and people with hemophilia in the United States, Europe, and Japan would continue to receive lifesaving supplies of the compound.
An estimated 26,000 Americans—most of them boys and post-adolescent men—had hemophilia in 1983. Their life expectancy had improved radically because of Factors VIII and IX; prior to 1970 few could hope to live past the age of twenty-five, with an average age of 11.2 years. But by 1980, people with hemophilia were averaging thirty-eight years of age.
When Curran, Evatt, and Francis met with blood industry and FDA representatives in January 1983, they had woefully little data on hand to argue for urgency because of AIDS. But they did know how rapidly hepatitis B had entered the blood supply, and statistics on infection among people with hemophilia were known to all in that room.
Several options were discussed, including use of a recently developed hepatitis test that could directly detect the presence of the virus (core antigen) in blood samples. Evatt argued that many people with AIDS—well over 50 percent—had histories of hepatitis B infection, and use of such a test could dramatically decrease the danger of contracting AIDS from blood products.
Blood bank representatives protested that the epidemiological link between hepatitis B and whatever caused AIDS was not as clear as Evatt indicated. Furthermore, they noted, many authoritative scientists were arguing that the disease wasn’t due to an infectious agent at all, but to “poppers†or “lifestyles.†For those who were willing to accept the notion of a single infectious cause of AIDS, there remained great reluctance to believe that there could be an asymptomatic carrier state of the disease that couldn’t be ruled out with a simple symptoms questionnaire. (Such an asymptomatic state existed, of course, for most blood-borne diseases.) Finally, they claimed that such testing would be expensive, adding a cost of two to five dollars per blood unit, which they would be forced to pass on to consumers.
Francis lost his temper. He pounded the table and raised his voice, accusing the blood bank officials of callous disregard of the health of millions of Americans.52 The meeting deteriorated amid hot tempers and accusations.
In the end, the group agreed to nothing. A course of voluntary action that Dr. Frederick Siegel had recommended six months earlier was adopted by some members of the industry: actively screen out gay, drug-injecting, and Haitian donors.53
On March 25, 1983, Assistant Secretary for Health Brandt formally recommended—but did not mandate—“interim measures to protect recipients of plasma, blood and blood products until specific laboratory tests are developed to screen blood for AIDS.â€
The three recommended measures were: to educate donors about who should refrain from donating, to teach blood drive workers how to recognize medical histories among donors that might be indicative of AIDS, and to establish systems for storing or disposing of suspected AIDS-contaminated blood.
Encouraging educated gay men to refrain from donating blood was relatively simple, and was largely achieved by the gay press. But discouraging injecting drug users from selling their blood and plasma was nearly impossible. As long as someone was willing to buy, they were eager to sell.
Convinced that a hepatitis core antibody t
est, however imperfect it might be, would offer a vital margin of protection to people with hemophilia, the NHF would continue lobbying the FDA well into 1983. Strangely, at a time when both hepatitis viruses and whatever caused AIDS were in the U.S. blood supply, the Reagan administration radically decreased the overall size of the Food and Drug Administration, reducing by 25 percent, among other things, the size of the staff dedicated to overseeing the blood industry. In the spring of 1983 FDA Commissioner Frank Young announced a 50 percent cut in the number of his agency’s blood industry quality control inspections. It would be more than five years before the repercussions of Young’s decision would come under review, and during that time the industry would grow dramatically. The American Red Cross alone would expand its blood program by over 150 percent. So by the time in 1988 when the FDA reconsidered its policies, most blood and plasma collection and processing facilities would have been left uninspected for three or four years.
The CDC and FDA would be at odds over the blood supply throughout 1983, and Assistant Secretary Brandt generally would side with the FDA’s “wait and see†approach. In November the National Hemophilia Foundation’s scientific advisory board decided to demand that the plasma industry use the hepatitis B core antibody assay to screen out as many contaminants as possible.
The FDA’s Blood Products Advisory Committee agreed to meet in Bethesda in December 1983 to debate the NHF’s demand. But industry representatives gathered in secret on the eve of the FDA session and devised a stalling tactic: they would call for creation of a task force, dominated by their scientists, that would spend several months examining the blood-testing issue and eventually tell the FDA that it was unable to reach a consensus.
The Coming Plague Page 48