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Factor VIII deficiency

Haemophilia A (also spelt Hemophilia A or Hæmophilia A) is a blood clotting disorder caused by a mutation of the factor VIII gene, leading to a deficiency in Factor VIII. It is the most common hemophilia. Inheritance is X-linked; hence, males are affected while females are carriers or very rarely display a mild phenotype. 1 in 10,000 males are affected. more...

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Signs and symptoms

Hemophilia leads to a severely increased risk of bleeding from common injuries. The sites of bleeding are:

  • joints
  • muscles
  • digestive tract
  • brain

The muscle and joint haemorrhages are quite typical of haemophilia, while digestive tract and cerebral haemorrhages are also germane to other coagulation disorders.

Diagnosis

The diagnosis may be suspected as coagulation testing reveals an increased PTT in the context of a normal PT and bleeding time. The diagnosis is made in the presence of very low (<10 IU) levels of factor VIII. A family history is frequently present, although not essential. Nowadays, genetic testing may also be performed.

The most important differential diagnosis is that of hemophilia B (also known as Christmas disease) or von Willebrand disease. The former is usually considered if factor VIII levels are normal in a person with a haemophilia phenotype. The latter is excluded on routine testing for that condition.

A very small minority of patients has antibodies against factor VIII that impair its functioning. Management of these patients is more complicated (see below).

Therapy

Most haemophilia patients require regular supplementation with intravenous recombinant factor VIII. This is highly individually determined. Apart from "routine" supplementation, extra factor concentrate is given around surgical procedures and after trauma. In children, an easily accessible intravenous port (e.g. Port-a-Cath) may have to be inserted to minimise frequent traumatic intravenous cannulation.

Some may manage on desmopressin, if the clotting factor is still partially active.

A particular therapeutic conundrum is the development of "inhibitor" antibodies against factor VIII due to frequent infusions. These probably develop as the body recognises the factor VIII as foreign, as the body does not have its own "copy". The problem is that in these patients, factor VIII infusions are ineffective. Recently activated factor VII (NovoSeven®) has become available as a treatment for haemorrhage in patients with haemophilia and factor inhibitors.

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The corrupting of Factor VIII - the hope of hemophiliacs became the deadly agent of AIDS; excerpt from 'And the Band Played On'
From Saturday Evening Post, 3/1/88 by Randy Shilts

THE CORRUPTING OF FACTOR VIII

January 1982, Centers for

Disease Control, Atlanta

Bruce Evatt enjoyed his work with hemophiliacs, and his lifetime research into the bleeding disorder had long ago made him the resident expert on hemophilia at the Centers for Disease Control. The disorder, which had plagued generations of European royalty, was determined by the hereditary information of just one molecule. Orders for this molecule's construction passed in genetic code from mother to son; the molecule determined whether or not the son's blood woult clot to stop bleeing. Hemophiliac sons lacked that ability, hence the name of their disorder, hemophilia, "Love of blook." Beyond the fascination with this molecule, Evatt found that hemophiliacs were simply a joy to work with. They were an intelligent, well-informed group who, in their lifetime, had experienced a scientific breakthrough that added decades to their typical life expectancy.

The invention of Factor VIII--a substance that, when injected, helped their blood to clot normally--had revolutionized thinking about longevity for America's 20,000 hemophiliacs. Before Factor VIII, a hemophiliac could expect two, maybe three, decades of a life crowded with visits to the hospital for voluminous transfusions. All that the transfusions could do, however, was replace lost blood. Factor VIII, injected into the blood with a clotting factor concentrated from thousands of blood donors, gave the necessary components that allowed the hemophiliac's blood to clot itself. The discovery gave the promise of a reasonably normal life span.

Bruce Evatt relished the optimism hemophiliacs shared. They organized, lobbied for research funding, and eagerly worked to improve their lot, not like people with cancer or chronic diseases who in despair just turned over and died.

Evatt's regard for hemophiliacs is what made the phone call from Florida so troubling in the first days of 1982. A Miami physician was convinced that Factor VIII had killed his patient, an aging hemophiliac how had died of Pneumocystis a few months ago. Couldn't the Pneumocystis protozoa have been transmitted in the clotting substance his patient injected?

Evatt assured the doctor that the filtering process during Factor VIII preparation prevented the transmission of bacteria and protozoa. Of course, smaller microbes, like viruses, could make it through the filtering, giving hemophiliacs an inordinately high rate of, say, hepatitis B. But the Pneumocystis bug was big enough to be caught by the filters. Evatt's careful speech exuded an aura of kindliness; it was difficult not to believe his reassurance.

Once off the phone, however, Evatt's face folded downward toward the despairing thoughts he had been trying to hold off. Already, CDC staffers like Mary Guinam and Don Francis were predicting cases of "gay pneumonia" in hemophiliacs and in blood-transfusion recipients. This could not only be the first such case but it could also provide some evidence that a virus was indeed responsible for the epidemic of immune deficiency among gay men. Evatt called the Food and Drug Administration, which has authority over blood products, to see whether its staff had heard of any similar problems. He also checked with the well-organized network of hemophiliac groups in case they had heard any reports of similar cases. None, Nor did [CDC technician] Sandra Ford's records turn up any pentamidine orders for hemophiliac patients. [Pentamidine is the drug used to treat Pneumocystis.]

The Florida case itself was problematical. Although a biopsy did confirm the Pneumocystis, the man's death made it impossible to go for any more precise immune assay [analysis]. The doctors had also made no autopsy, leaving the possibility that some undiagnosed tumor or lymph cancer had caused the immune supression necessary for the pneumonia to take root.

Harold Jaffe of the Kaposi's Sarcoma and Opportunistic Infections Task Force explained the problems to CDC Director Bill Foege. An old hand at epidemiology, Foege appreciated the gravity of the case, not only for hemophiliacs and blood-transfusion recipeints but also for opening the way to finally nailing down something as the cause of the epidemic, even if it were only a generic lable like virus. However, he knew there were too many variables.

"If it's real, there'll be another one," he told Jaffe. "And then we'll know."

Evatt told Sandy Ford to be alert for any pentamidine orders that might list hemophilia as an underlying medical condition, and the uneasy months of waiting began.

June 11, Centers for

Disease Control, Atlanta

Sandy Ford called Dr. Evatt as soon as the order came in. Sandy, who had first alerted the CDC to the GRID [later changed to AIDS] epidemic last year, had even worse news to break to Evatt.

It had happened, Ford told him. An order for pentamidine had come in from Denver. The Pneumocystis victim, the doctors had said, was a hemophiliac.

That night, Evatt's associate in the Division of host Factors, Dr. Dale Lawrence, took a flight to Stapleton International Airport in Denver.

June 14, Denver

With his white shirt, plaid tie, black oxfords, and thinning dark hair that fell over earnest dark eyes, Dr. Dale Lawrence looked like everybody's favorite biology teacher in high school. He sounded like a serious instructor too, soft-spoken even as he strained to put his words together just right so everything he said would be easy to understand. He had to ask all these questions, he told the stunned wife of the hemophiliac patient, because so much was at stake.

Although Lawrence had worked for a year with CDC's Division of Host Factors on issues of genetics and susceptibility to GRID, he had been to enough Task Force meetings to know what needed to be asked. He had to positively eliminate the chance that the main might have been involved in gay experiences or, perhaps, some kind of drug use or medication that could have engendered his immune deficiency. lawrence's intense investigation the earlier few days had eliminated everything else. Just that morning, he had gone to the local blood center. Blood-bank officials were very skittish about his arrival; Lawrence knew why. Just one or two documented hemophiliac GRID cases would severely shake the foundations of the blood-banking industry.

Lawrence carefully drew out grids of all the different batches of the Factor VIII clotting factor that had been injected into dozens of other hemophiliacs served by the same Hemophilia Treatment Center in the Denver area. Maybe there was just one bad lot that was making people sick, and the Pneumocystis diagnosis was a wicked coincidence. Looking back at three previous years, however, he could find no single such lot.

Instead, Lawrence went back to the wife of the man wheezing on the ventilator at the University of Colorado Medical Center. The couple's trouble story was laid out. The man, a janitor, had struggled against his disease for a lifetime, already living decades beyond what doctors had predicted when he was born. The uncontrolled bleeding in his joints had left him partly crippled, but he toiled to eke out a living for his wife and children just the same. Factor VIII, of course, had been a godsend, but now he was in there dying. Wasn't there anything anybody could do?

At the end of the conversation, Lawrence felt he had eliminated other probable routes of infection. Bruce Evatt was convinced that GRID was being spread through Factor VIII even before Lawrence returned with the final results of his investigation. Evatt had suspected it for months, after the first Florida man had died of Pneumocystis. The Colorado case was the clincher. Because bacteria, protozoa, and one-celled microbes were easily weeded out of the Factor VIII during its preparation process, this meant that GRID was caused by a virus, the only organism small enough to pass through the filters.

Both Lawrence and Evatt knew there would be more GRID cases among the hemophiliacs soon and blood-transfusion cases would follow. Because of their exposure to vast numbers of donors, the hemophiliacs simply had the misfortune to get it first, like promiscuous gay men in teh late 1970s.

July 2, Atlanta

Bruce Evatt heard of still another case of immune suppresion in a hemophiliac in Canton, Ohio, and now he saw clearly what was ahead. GRID was an infectious disease caused by a virus that could be spread through the blood. The nation's blood supply was already contaminated with the virus. A meeting of blood-industry officials would be needed soon; emergency measures would be needed to save lives.

January 4, 1983, Centers for

Disease Control, Atlanta

Don Francis pounded the table with his fist. the other officials from the CDC exchanged vaguely embarrassed glances. The blood bankers were becoming visibly angry.

"How many people have to die?" shouted Francis, his fist hitting the table again. "How many deaths do you need? Give us the threshold of death that you need in order to believe that this is happening, and we'll meet at that time and we can start doing something."

As far as Francis was concerned, the assembled leaders of the blood-banking industry were about to take a course of action that could, at best, termed negligent homicide, although Francis was known to drop the word "negligent" in private discussions on the issue. The blood banks refused to believe that transfusion-associated AIDS existed, and now they were going to kill people because of it, Francis thought. It was that simple.

Privately, almost all of the officials from the Centers for Disease Control agreed with Don francis, although they were groaning to themselves that he had shown so little politesse as to say it aloud.

The meeting of this ad hoc advisory committee for the U.S. Public Health Service had been fashioned to embrace every group with an interest in the burgeoning epidemic, including the American Red Cross, the American Association of Blood Banks, the National Hemophilia Foundation, the National Gay Task Force, and the Pharmaceutical Manufacturers Association, which represented the commercial blood-products makers, as well as the representatives from the National Institutes of Health and the Food and Drug Administration, the one federal agency that has regulatory power over the blood banks. A congressional aide, Tim westmoreland, was there too, as well as reporters from most of the major medical journals and the Philadelphia Inquirer, the only major newspaper to provide thorough coverage of the meeting.

The CDC had hoped the assembly would produce some action to arrest the threat the new syndrome posed to the nation's blood supply. Even before the meeting opened, however, it was clear that each group had come with its own agenda, and on most lists stopping the potential spread of AIDS was secondary. Blood bankers were openly skeptical of the CDC claim that AIDS could be transmitted through blood. Some FDA officials remained unconvinced that AIDS even existed. Gay groups already had condemned any call for screening of blood donors as "scapegoating" homosexuals. The San Francisco Coordinating Committee for Gay and Lesbian Services, chaired by Pat Norman, issued a policy paper asserting that donor screening was "reminiscent of miscegenation blood laws that divided black blood from white" and "similar in concept to the World War II rounding up of Japanese-Americans in the western half of the country to minimize the possibility of espionage."

As Tim Westmoreland saw the player assemble in the CDC's Auditorium A, all facing off at tables positioned in a large square, he sensed that this would not be a polite meeting of scientists engaged in the usual academic one-upmanship. There were interests to guard and turfs to protect. In most reminiscences, the participants would simply refer to the conference as "that horrible meeting."

Jim curran [the director of the CDC's AIDS Task Force] described the two options the blood industry could take. Either they could adopt guidelines to keep people at high risk from donating blood of they could start testig blood to try to weed out likely AIDS carriers. Curran gave the blood bankers a sobering conclusion to his talk: there was at least a one-year incubation period for AIDS. No matter what course the blood industry took that day, it would have no effect for another year, during which still more cases of blood-borne AIDS would incubate and emerge.

It was left to an immunologist, Thomas Spira, one of the CDC's top virologists, to make the case for the testing of all blood products, the route that the AIDS Task force desperately hoped blood bankers would follow. Although no test for AIDS itself yet existed, Spira had spent his past weeks testing the blood of AIDS patients for other markers. The trait that distinguished the blood of AIDS suffers was not difficult to find, considering that virtually everybody in AIDS risk groups--gay men, intravenous drug users, and hemophiliacs--had also suffered from hepatitis B at some point in their lives. Although the hepatitis virus usually disappeared after recovery, the blood still harbored intibodies to the core of the virus. Thus, Spira had found that 88 percent of the blood from gay AIDS patients contained hepatitis-care antibodies, while all the blood from AIDS patients who were intravenous drug users had the antibodies, and 80 percent of people with lymphadenopathy carried the antibodies. The test might not screen out all AIDS carriers, Spira suggested, but it would eliminate enough to sharply reduce the threat of transmitting AIDS through transfusions.

CDC officials hoped the data on the testing for a surrogate marker would point the discussions toward what blood banks and commercial blood-products manufacturers could do about AIDS. Instead, the discussion turned into a heated debate about the reality of transfusion AIDS.

"donht oversate the facts," said Dr. Aaron Kellner, president of the New York Blood Center. "There are at most three cases of AIDS from blood donation, and the evidence in two of these cases is very soft. And there are only a handful of cases among hemophiliacs."

Besides, Dr. Kellner said, the proposed testing would cost his center $5 million to implement. False-positive test results would result in the unnecessary disposal of blood that wasn't infected with AIDS. "We must be careful not to overreact," he said. "The evidence is tenuous."

Dr. Joseph Bove, the director of the blood bank at Yale University Hospitals and chair of the FDA advisory committee on blood safety, joined in the objections. "We are contemplating all these wide-ranging measures because one baby got AIDS after transfusion from a person who later came down with AIDS [the nation's first AIDS-by-transfusion case, confirmed in October 1981, involved a San Francisco infant] and there may be a few other cases."

Assistant CDC director Jeffrey Koplan was taken aback. "To bury our heads in the sand and say, 'Let's wait for more cases," is not an adequate public-health measure," he argued.

Dr. Bruce Evatt tried to reassert the data about hemophiliacs. AIDS simply did not happen among these people before 1982. In only the past year, however, 6 of just 100 hemophiliacs in Ohio were dead of AIDS and 3 more were suffering from severe blood problems associated with the syndrome. Nearly 10 percent already were sick with something having to do with AIDS, Evatt said. What kind of proof did the blood banks need?

Dr. Selma Dritz from the San Francisco Department of Public Health sympathized with the blood bankers. She knew that vast sums of money were involved with any surrogate testing of blood. She also knew that a more moderat e proposal to screen out groups at high risk for AIDS from blood donors would severely hurt urban blood banks that relied on civic-minded homosexuals as an essential part of their donor pool. Still, Dr. Dritz had the health of her city to tend to and a board of supervisors to answer to. Like so many health officials, her data was hardly reassuring to the blood bankers. "Of 140 [AIDS patients], 10 or 11 had donated whole blood in the previous few years," she said. "We don't know how many others sold their blood or plasma at commercial centers."

At the very least, all people at high risk for AIDS should be ordered to stop giving blood, Dr. Dritz thought. Given the fact that carriers could be perfectly healthy while donating a fatal dose of blood, as was the case with the San Francisco baby, Dr. Dritz felt all gays should stop donating.

As the blood bankers got back to arguing the specific case histories of CDC's transfusion AIDS victims, Don Francis started shouting about the "threshold of action." The evidence that the latency period might be long, much longer than anyone suggested, fueled Francis' conviction that the job of the CDC was not merely to monitor the spread of AIDS and count its victims, but to control the disease. "We can't constantly be reacting," he pleaded, "and be constantly behind the eight ball."

Everybody could tell now the meeting was going badly, very badly. The blood bankers were worried about money and the costs of drawing new donors; they were also suspicious of all the reporters covering the conference. Was the CDC trying to pressure them into action? FDA representatives were also wary of the CDC and were slightly irritated that the FDA's turf had been so brazenly invaded by the hotshot epidemiologists from Atlanta. Blood policy was FDA terrain and would stay that way.

Representatives from gay organizations sided with the CDC on surrogate tests of blood but firmly opposed taking any action to screen blood donors, saying the screening would pose serious civil rights questions. "So-called 'fastlane' gays are causing the problem, and they are just a minority of male homosexuals," offered Dr. Bruce Voeller, representing the National Gay Taks Force. "You'll stigmatize at the time of a major civil-rights movement a whole group, only a tiny fraction of whom qualify as the problem we are here to address. . . . Also, many gays don't self-identify as such and won't respond to the questionnaire."

Representatives from hemophiliac organizations were stunned by the gay perspective. What about a homophiliac's right to life? they asked.

After a lunch break, the blood bankers returned even more resolutely opposed to blood testing, arguing almost solely on fiscal grounds. Although largely run by nonprofit organizations like the Red Cross, the blood industry represented big money, annual receipts of a billon dollars. Their business of providing the blood for 3.5 million transfusions a year was threatened. Already the high cost of blood had created new markets for self-donation. Prices had to be competitive, blood bankers knew. The cost of testing for hepatitis antibodies, Dr. Kellner from the New York Blood Center suggested, would be $100 million annually for the entire nation. That was simply too much. Instead, he proposed, perhaps, some pilot studies in New York, Los Angeles, and San Francisco.

The for-profit blood-products manufacturers, however, did not enjoy the cartel on their merchandise that the nonprofit blood centers held. With the fear of direct competition for their market, the spokesman for Alpha Therapeutic Corporation announced that his firm, which manufactured Factor VIII, woudl immediately begin screening donors and exclude all people in high-risk groups, including all gays, whether or not they appeared to be "fast-lane." The position infuriated the gay representatives.

The goal of the meeting was to forward some consensus recommendations to Dr. Edward Brandt, who, as assistant secretary for health of the U.S. Department of Health and Human Services, headed the Public Health Service. At the end of the meeting, CDC's Jeffrey Koplan, the chair, began proposing consensus recommendations. Bruce Voeller suggested a resolution opposed to deferral of high-risk donors; the proposal was defeated soundly on a voice vote. Other proposals met similar fates or were modified so extensively that they were rendered meaningless. The meeting adjourned with no recommendation or agreed-upon course of action. Things would simply go on as they were, as if nothing was happening.

Don Francis was enraged. The blood banks were going to kill people, he fumed, and the FDA wasn't going to do a damn thing about it.

His colleague Harold Jaffe, though not given to such dramatic pronouncements, was equally disappointed. He couldn't believe what he had heard from the blood bankers. They did not want to believe their industry could be involved in something as horrible as AIDS, so they had simply denied the problem existed. To a large extent, the same thing was happening in the gay community, Jaffe knew, but the blood bankers were doctors and scientists of a sort. They were supposed to be rational and most had sworn to uphold the Hippocratic oath.

It had been a year since Bruce Evatt had heard of the first suspected AIDS case in a hemophiliac. He had expected more cases at that time, but the problem was growing much faster than anyone had expected. He had not anticipated that the CDC would be so definitively thwarted in its influence on public policy. The CDC had stood alone and lost. In history, he knew, it would all go down as a stupid mistake, a terribly stupid mistake.

The year 1983 was going to be that kind of time for the AIDS epidemic. There would be denial on all fronts, leading to stupid mistakes that would cost thousands of lives in the short term and tens of thousands in the long term. The lost opportunities of 1982 would be explained later with the chorus "How were we to know?" This had no meaning in 1983. By then, vast numbers of people knew better, but confronted with knowledge and the chance to do something, they usually did the wrong thing, if they did anything at all. At the time, their postures seemed like the right thing to do in order to preserve civil rights or, say, the economic viability of the blood industry. The problem, of course, was that such considerations constantly overshadowed concerns of medicine and public health.

Two days later, after the fateful meeting in Auditorium A, the American Association of Blood Banks convened a Washington meeting with all the major blood-banking organizations, as well as the American Red Cross, the National Gay Task Force, and the National Hemophilia Foundation.

Under prodding from gay representatives, the groups issued a joint statement reiterating and blood-banking industry's opposition to donor screening. "Direct or indirect questions about a donor's sexual preference are inappropriate," the statement said. Dr. Roger Enlow, a gay New York City physician and a leader of the American Association of Physicians for Human Rights, heralded the policy. "We've preserved not just gay rights," he said, "but the human right to privacy and individual choice."

January 7

Pressure mounted on the blood industry in the weeks after the Atlanta meeting to protect "innocent victims." The National Hemophilia Foundation enraged gay activists by calling for "serious efforts" to bar all gay men from donating blood. The for-profit blood-products manufacturers soon fell in line with the foundation, unable to take the commercial risk of offending hemophiliacs, a major market for blood products. The nonprofit blood bankers, however, continued to oppose such deferrals as "premature." Meanwhile, gay groups across the country were organizing to oppose what they called the "quarantine" of gay blood.

Blood bankers were quick to pick up the gay rhetoric. At an AIDS study group at the University of California in San Francisco, where Dr. Marcus Conant was trying to engineer a strong university position for hepatitis antibody testing, the staid medical director of San Francisco's Irwin Memorial Blood Bank took his arguments against surrogate testing straight from the lexicon of militant Gay Freedom Day speeches. The hepatitis testing would end up marking gay men with a "biological pink triangle," asserted Dr. Herb Perkins [the medical director of Northern California's major blood bank], alluding to the emblems gays wore in Hitler's death camps. "If 95 percent of gay men are antibodycore positive, do we want them marked to exclude all blood with this marker?" he asked.

Dr. Conant was unimpressed by Dr. Perkins' oratorical flourishes. He knew that more than civil rights was involved with the blood banks' refusal to test blood or defer donors. It was dollars and cents, both in increased testing expenses and for the larger recruiting drives needed to replace gay donors. Dr. Conant had no doubt that self-deferral of donors could prove to be a disaster. Too many gays were in the closet, and those who weren't tended to view AIDS as a problem for sleaze-bag gays, the bad homosexuals, not themselves.

Within two weeks, Dr. Conant had enlisted the major AIDS experts from UCSF, as well as the highly respected dean of the medical school, to issue a public plea to blood bankers in New York, Los Angeles, and San Francisco to start hepatitis-core antibody testing as a regular procedure.

The blood banks ignored the statement. Dr. Perkins insisted that the call for surrogate testing was "not based on any rational evidence that it would screen out everyone with AIDS, or anyone who was incubating AIDS."

March 3, 1983, Department

of Health and Human Services,

Washington, D.C.

Throughout February, pressure had continued to mount on the federal government to move to protect the blood supply. The nine-month stall on a national blood policy, dating back to the discovery of the hemophiliac cases, could not be sustained. Sensitive to the demands of hemophiliacs, virtually all the private pharmaceutical companies had fallen in line with the National Hemophilia Foundation's guidelines restricting donations from gay men and other high-risk groups. The federal government, meanwhile, had to steer its policy through wars between the Centers for Disease Control and the Food and Drug Administration, as well as the pressures exerted by blood bankers, easily agitated gay groups, and congressional representatives promoting their various interests.

The Centers for Disease Control took the hard line in their proposed guidelines, calling for both blood testing and mandatory exclusion of all people in high-risk groups, not merely the voluntary self-deferral the blood banks wanted. Taking its cues from the blood industry, the Food and Drug Administration favored more moderate restrictions. The blood bankers were worried that they would not have enough blood and would suffer economically if all gays were restricted; they also fretted about accusations that they would look like antigay bigots if all homosexuals were summarily rejected.

The government's final recommendation was as broad a compromise as could be worked out. It was issued as the policy of the U.S. Public Health Service, the umbrella agency for the CDC, National Institutes of Health, and FDA. "As a temporary measure, members of ]groups at] increased risk for AIDS should refrain from donating plasma and/or blood," the guidelines said. High-risk people, however, did not include all gays, according to these guidelines, but merely those who were sexually active, had overt symptoms of immune deficiency, or had engaged in sexual relations with people who did. There would not be the hepatitis antibody blood screening that the CDC wanted. Instead, the guidelines called for studies to evaluate screening procedures. With the weight of the Public Health Service behind them, the American Red Cross, the American Association of Blood Banks, and the Council of Community Blood Centers had no choice but to announce that they would comply.

The Public Health Service guidelines came seven months after the CDC first had proposed policy for the AIDS blood problem in July 1982, and two months after "that horrible meeting" in Atlanta. Between that January 4 meeting and the March 4 publication of the guidelines in the Morbidity and Mortality Weekly Report, nearly one million transfusions were administered in the United States.

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