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Philadelphia Inquirer; FINAL Section: EDITORIAL REVIEW & OPINION Page: E01

SUNDAY April 16, 1995

It is one of the little-known stories of World War II. Had more attention been paid to it, hemophiliacs in the United States might not be dying now at the rate of one a day.

It was 1944, five years into the war.

At Schick General Hospital in Clinton, Iowa, military doctors were treating a steady stream of wounded men shipped home from overseas. By year's end, Capt. Emanuel M. Rappaport of the U.S. Army Medical Corps had detected a disturbing pattern.

Many of the soldiers were coming down with hepatitis, a viral inflammation of the liver. The men had served in different parts of the world but had one thing in common: Battlefield transfusions.

The plasma most received had been drawn from a number of different pools, each made up of donations from dozens of people.

The implications soon were clear: Hepatitis was spreading through plasma transfusions. And plasma pools could become tainted if only one of the dozens of donors carried the virus.

In 1945, Rappaport went public with his findings, which by then were apparent to many other doctors. His study, published in July 1945 in the Journal of the American Medical Association, concluded not only that transfusions were to blame but that the "pooling of plasma probably increases considerably the incidence of jaundice (hepatitis) among the recipients."

In a larger study a year later, he proposed more stringent screening of donors and urged immediate research on ways to kill viruses in blood products.

"It is likely that this syndrome will be encountered . . . more frequently in the future," he wrote.

Half a century later, that warning is at the heart of scores of lawsuits involving the spread of another virus through blood. This time, the patients are hemophiliacs, and the disease is AIDS.

A key issue in the litigation is why heat-treating techniques that killed hepatitis - techniques first used by Army-financed scientists back in the 1940s - were not perfected until 1983 for blood-clotting products used by hemophiliacs. By 1983, most of the nation's hemophiliacs had contracted the AIDS virus through blood-clotting medicine made from pooled human plasma.

An estimated 8,000 to 10,000 U.S. hemophiliacs were infected with HIV, the AIDS virus, in the late 1970s and early 1980s. Also infected were thousands of hemophiliacs in Canada, Europe, Japan and elsewhere who used American products - as well as some wives, girlfriends and newborns, who contracted HIV from them. (Hemophilia, caused by too few clotting proteins in the blood, primarily affects men.)

Today, hemophiliacs and their loved ones are demanding to know why the federal government did not require sooner that manufacturers purify the clotting products.

The manufacturers say they did all they could to make hemophilia medicines safe, given what was known at the time. They also say that until the early 1980s, they did not know how to kill viruses without destroying plasma's blood-clotting proteins.

The history of how these decisions were made, and of how the government failed to protect the lives of thousands of people adequately, is of more than academic interest, because new viruses - and newly discovered forms of existing ones, including HIV and hepatitis - are appearing all the time. At stake could be the health not only of hemophiliacs but of 40 million other people who receive plasma products each year.

At a recent conference in Washington, blood experts from around the world said it was only a matter of when - not if - the next dangerous virus gets into the blood supply.

In early 1940, as it became apparent that the United States might enter the war, the Army's medical department started planning for a serious problem: shock resulting from battlefield blood loss.

Whole blood, the doctors feared, was too fragile to survive the trip to faraway war zones. So in 1941 and 1942, military records show, seven commercial laboratories were hired to freeze-dry plasma, the yellowish, fluid portion of blood.

Among the labs were Cutter and Hyland, two of the four manufacturers that are now defendants in the lawsuits filed by hemophiliacs. Today, Cutter is a subsidiary of Miles Inc. of Pittsburgh, while Hyland is part of Baxter Healthcare Corp. of Deerfield, Ill.

As the war raged and casualties mounted, so did hepatitis cases.

World War II marked the first time that blood products were used widely, and they helped save countless lives. But in Iowa, Capt. Rappaport knew that other doctors, in the United States and in Europe, were observing outbreaks similar to his. The medical literature included several reports on what then was called homologous serum jaundice, or what's now known as hepatitis B.

Rappaport's paper about his patients was published in 1945. In a larger study a year later, he found that "hepatitis following the use of pooled plasma occurred 14 times as frequently as after the therapeutic use of whole blood."

Seventeen years after Rappaport published his study, his conclusions were supported by the Army's Office of the Surgeon General, which reported that "numerous" wartime cases of homologous serum jaundice had resulted from transfusions. By late 1945, "pooled plasma was indicted as the vehicle," reads the 1962 Army report.

The report goes a step further, concluding that the larger the plasma pool, the more likely it was to contain hepatitis. During the war, according to the report, each pool contained plasma from 50 or more donors. And the pools grew progressively larger as the war went on.

"In retrospect, what happened was clear," the report continues. "A single transfusion of blood is likely to cause jaundice in only a small percentage of the recipients. When, however, blood is pooled, as it is when plasma is processed, the chances of contracting jaundice are correspondingly increased."

Attempts, many funded by the military, were made in the 1940s to kill hepatitis in whole plasma while retaining all its therapeutic benefits. The studies were unsuccessful, according to military records, because the ailment's cause was unknown and because no laboratory animals were known to be susceptible to the virus.

Experiments with human volunteers from the military, prisons and state hospitals were abandoned after it became clear that plasma-induced hepatitis "carried a high risk of mortality" and illness, one study said.

Once the conclusions drawn by Rappaport and other researchers became well known, plasma fell out of favor as a substitute for whole blood. By then, the war was winding down and doctors had an alternative product: albumin, a plasma component.

Doctors knew that albumin, because it was heat-treated, was unlikely to cause hepatitis. Heating at 140 degrees Fahrenheit for 10 hours killed the virus but did not kill albumin's therapeutic proteins. Most scientists thought the same temperature would render plasma worthless.

Interest in plasma was revived in 1950 when an Army-funded team led by J. Garrott Allen, then of the University of Chicago, reported that prolonged heating could kill hepatitis. Allen's method, which called for heating liquid plasma at about 90 degrees Fahrenheit for between three and six months, was reaffirmed in followup studies.

The method, though, also killed blood-clotting proteins. Allen was not overly concerned about this because he was seeking primarily to prove that liquid plasma was still useful as a substitute for whole blood.

By the time Allen's study was published, the Korean War had begun. Army doctors were treating the wounded with pooled plasma that had been irradiated with ultraviolet light in an attempt to kill hepatitis. It didn't work: Nearly 22 percent of the men who received plasma contracted hepatitis.

In 1958, two more studies supported Allen.

Some blood banks began using his technique.

Many researchers took aim at hemophilia, an inherited condition, usually passed from mothers to sons, in which there are few or no clotting proteins in the blood. The scientists tried to separate the proteins from plasma, with little success.

Then, in 1964, hemophilia treatment was revolutionized. Stanford University scientist Judith Pool - who had studied under Allen - and her colleagues developed cryoprecipitate, a human plasma residue rich in clotting proteins. It came from a single donor or a few donors - not from a plasma pool - and so was less likely to carry hepatitis or other viruses.

For the first time, hemophiliacs could treat their disease with injections at home instead of in a hospital.

Two years later came the next major stride: Baxter's Hyland division further refined cryoprecipitate to make the world's first freeze-dried blood-clotting concentrate. It was called Factor VIII, after the most common clotting protein.

The products were made from increasingly larger plasma pools, which made production more economical. While the Army had worried about pools with up to 50 donors, the new clotting drugs were made from pools with thousands - eventually tens of thousands - of donors.

Then came a 1968 study by Allan G. Redeker, a University of Southern California physician who asserted that Allen's heating method did not work so well after all. Experts called for renewed caution with plasma.

The National Research Council, which had endorsed Allen's heating technique, changed its mind, saying the Redeker study meant that "serious doubt is cast on the safety of all pooled human-plasma preparations."

The council said it saw few good reasons to use whole plasma, especially since albumin was safer. Heat-treated plasma was worthless for blood clotting since it was well known that heat killed those proteins, the council noted.

Allen, who by then had moved on to Stanford, countered that Redeker's work had contained serious flaws. And in an Army-financed study published in 1969, Allen wrote that the National Research Council had not done its homework.

He said Redeker had relied on plasma from two commercial operations, Hyland and Courtland Laboratories, in Los Angeles. Those labs, he said, used large pools of plasma from "skid row" donors, who sold their blood for money. The pools, he said, were therefore far more likely to carry disease and had to be heated longer.

What's more, Allen said, executives at the two labs admitted to him that neither the council nor government regulators had made any effort to inspect company records. Allen said there was evidence that the labs had not adhered to his standards.

By the time Allen's rebuttal was published, the National Institutes of Health had already approved the first freeze-dried blood-clotting concentrates for sale.

They were not heated.

And they were made from pools containing the plasma of thousands of donors, most of them paid.

In 1970, a study by researchers at the National Institutes of Health, published in the Journal of the American Medical Association, warned that just one unit of hepatitis-contaminated plasma could contaminate an entire pool. Diluted 10 million times, it still was infectious.

By the mid-1970s, most American hemophiliacs were taking the new, easy-to-use concentrates, and government-funded hemophilia-treatment centers had been established to offer comprehensive care and training in use of the medicines. Life expectancy and life quality for hemophiliacs had improved considerably.

It wasn't long, though, before hepatitis from blood products had become a leading killer of hemophiliacs. But the government, manufacturers of the blood-clotting concentrates, and some doctors called this an acceptable risk, given the medicine's huge benefits, and federal regulators allowed the medicines to be sold, with labels warning about hepatitis.

The drug industry said it needed too much plasma to rely solely on volunteer donors. No aggressive action was taken or demanded by the government to kill hepatitis in blood products. The companies were ordered to use the best available donor-screening tests for hepatitis B, but the tests were not sensitive enough to detect the virus every time. Some scientists, meanwhile, said the products were dangerous.

In a 1974 letter to federal health officials, Judith Pool, of Stanford, warned against a proposed national blood policy that allowed the continued use of paid donors for hemophilia drugs. By then, studies had found a strong association between paid donors and hepatitis in recipients.

Paid donors were more likely to harbor viruses because so many lived in poor areas that were breeding grounds for disease, the studies said. The World Health Organization objected, in particular, to what it called the exploitation of donors in Central and South America, Asia and Africa, where numerous commercial plasma-collection centers had been set up in the 1960s and '70s.

The proposed policy, Pool wrote, "in no way requires or even encourages the use of volunteer blood . . . but assumes a continuation of the dangerous, expensive, wasteful and unethical purchase of plasma by pharmaceutical houses. . . ."

By 1975, the World Health Organization was advocating an all-volunteer system of plasma donation. Federal regulators agreed with the industry's argument that the benefits outweighed the risks.