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94-  Hemo Found. Chief Knew

Title: Hemophilia Foundation Chief Knew Of Aids Risk In 1984

By: Donna Shaw

Date: November 3, 1994

Source: The Philadelphia Inquirer

Blood-clotting drugs so improved his life that their possible contamination with the AIDS virus in the early 1980s was “an irrelevancy,” according to Donald S. Goldman, a former president and board chairman of the National Hemophilia Foundation.

In a recent deposition, Goldman also said that the foundation’s co-medical director, Louis Aledort, told him in early 1983 that it was pointless to take any clotting concentrates tainted with the virus off the market – because it was likely that all of the products contained the virus.

Aledort, Goldman said, told him that “the risk of the increased cost and the decreased supply was not worth the benefit” of a recall, since the drugs were so essential to patients.

So in 1984, when clinical trials of a diagnostic test determined that most people with hemophilia carried antibodies for the AIDS virus, Goldman said that he and others at the foundation found this “reassuring.” It suggested, he said, “that people were already exposed, and having been exposed, they were immune.”

The statements of Goldman, a severe hemophiliac who now is a Superior Court judge in New Jersey, are contained in a pretrial deposition he gave in September as a witness in a class-action lawsuit filed by people with hemophilia who contracted the AIDS virus from blood-clotting medicine.

A secretary to Aledort, who left the foundation’s employ in late 1983 and stayed on for a time as an unpaid adviser, said he was unavailable for comment.

As The Inquirer reported last week, at least 10,000 of the nation’s 20,000 hemophiliacs contracted the AIDS virus from clotting medicines in the early 1980s. Today they are dying from AIDS at the rate of one per day – as many as 3,000 deaths so far, it is estimated. The first AIDS cases among hemophiliacs were reported in mid-1982.

The lawsuit, filed last year in Chicago federal court, is against the foundation and four drug companies that made the medicines: Rhone-Poulenc Rorer Inc. and a subsidiary, Armour Pharmaceutical Co. Inc., both of Collegeville; Miles Inc., of Pittsburgh; Baxter Healthcare Corp., of Deerfield, Ill.; and Alpha Therapeutic Corp., of Los Angeles.

The lead plaintiff, Jonathan Wadleigh, learned in 1984 that he’d been exposed to the virus. His foundation-affiliated doctor, he says, told him not to worry, because only people in high-risk groups were proceeding to fully developed AIDS. Wadleigh did not know he had AIDS until January 1993, when he was notified by letter. His first symptoms showed up three months later.

The plaintiffs say the manufacturers should have been purifying their products before AIDS erupted, after it became apparent in the 1970s that the products transmitted hepatitis. The suit says the foundation did not take a stronger stand because it was financially dependent upon the manufacturers.

The manufacturers say they acted properly and responded to the epidemic as quickly as possible, given that so little was known in the early years about how AIDS was transmitted.

In the mid-1980s, the companies began selling heat-treated medicines that were purer, and HIV contamination was nearly eliminated.

In his deposition, Goldman said that when the foundation did try to force a cleanup of potentially tainted products, it got little support from the U.S. Food and Drug Administration.

“The FDA made it absolutely clear to those of us involved in NHF that it

neither had the capacity, the legal authority nor the willingness to attempt to recall product under those circumstances, and that unless the NHF could obtain a voluntary withdrawal of those products, there was nothing the FDA could or would do,” Goldman said.

Responding to questions from Wayne Spivey, a Philadelphian who is one of the lead attorneys for the plaintiffs, Goldman said his understanding of the FDA’s position was that “large numbers of people within the scientific community” believed AIDS “was not transmissible by blood or blood products.”

An FDA spokesman said earlier this week that he could not comment while the matter was in litigation.

Goldman, who described himself as a heavy user of the clotting

concentrates, was a foundation board member from 1979 to 1988, and chairman

from 1983 to 1984. He was the foundation’s president from 1984 to 1986.

In his deposition, he said he had been exposed to hepatitis; under an agreement between the lawyers on both sides, he was not asked his HIV status.

The blood-clotting concentrates were made from pools containing tens of thousands of units of human blood. One tainted unit, then, could contaminate the whole pool.

Goldman said that he and most of the foundation’s leadership disagreed with Aledort’s position on recalls, believing “that doing something had some value.”

Goldman said he had a long-running feud with Aledort.

The foundation board was on record in early 1982 as favoring recalls of products suspected of having been tainted by the AIDS virus.

On the other hand, Goldman said, if one of the drug manufacturers had come to the foundation and said, ” ‘There’s an AIDS donor in every lot that exists, what are we going to do, pull it all off?’ I think . . . we probably would have agreed with Dr. Aledort under those circumstances.”

Goldman said he believed at the time that stricter FDA regulation of the products should not occur if it meant higher prices and reduced availability.

“I mean, there’s a weighing process involved,” he said. “Let me put it this way: The concern of myself and most persons with hemophilia during the entire period of time had to do with access and availability.”

Goldman said that as early as December 1982, he believed the AIDS virus was transmissible through blood products.

“It only made sense as an effective working assumption,” he said, since it seemed so similar to hepatitis in terms of transmission.

But he was more concerned, he said, with preserving the lifestyle that the clotting concentrates had given him.

Goldman described what it had been like to have hemophilia before clotting

concentrates came on the market in the 1970s. He said he missed 100 out of 180 school days as a high school senior in 1962, and was taken by stretcher to his National Merit Scholarship qualifying test. In his first year of college, he got around in a wheelchair or a golf cart.

So, when he started using the concentrated clotting medicines and heard reports they might carry hepatitis, that was “an absolute irrelevancy.”

He felt the same way, he said, even after the AIDS virus came along.

Because of the medicine, Goldman said, he was able to go to law school, have a career and family, “and participate in life the way I was able to participate in it.”

Most people with hemophilia whom he talked to at that time agreed, he said. They felt that if “we all ended up dying at 40 or 50 or whatever the case might be, then so be it.”

In retrospect, he said, the foundation might have clung to the comparison with hepatitis too closely, in that it was assumed that having antibodies might mean people were immune from the disease.

In his deposition, Goldman also said:

* Manufacturers of clotting drugs sometimes threatened to withhold their

financial support if the foundation took positions opposed by the companies. In the only example he said he could recall, Goldman said Baxter, through its Hyland Therapeutics division, once dropped its financial support of a foundation nursing program after the foundation criticized a Hyland marketing plan.

Goldman said Hyland’s plan called for the company to give medicine directly to patients along with per-capita payments to hemophilia-treatment centers. Aledort and the foundation considered this system a “payoff,” Goldman said.

The four companies were regular contributors to the foundation. At the peak in 1982, they accounted for 22.8 percent of the NHF annual budget, according to foundation documents.

A Baxter spokeswoman said the company generally does not comment on pending litigation and would not make any comment on the case.

* In 1985, Miles attorney Duncan Barr wrote and submitted to the foundation board a proposed resolution that would put the board on record as opposing ”virtually any class action” against the manufacturers. The matter was placed on the October 1985 foundation board’s agenda; Barr was invited to speak on the resolution’s behalf.

At the time, a California woman, Kathleen Gannon, was suing Miles and its Cutter Biological division, blaming the company for her husband’s death from AIDS. She was seeking to have the suit certified as a class action.

Gannon’s attorney, Goldman said, was not invited to the meeting, or asked to provide input. The feeling was that this was “a poor idea,” he said.

Goldman said the board eventually approved a modified resolution that opposed only the Gannon case as a class action, on the premise that it would violate privacy by requiring a list be compiled of HIV-positive hemophiliacs.

Gannon lost her case.

Goldman said he found out years later that the NHF resolution was submitted by drug-company lawyers in opposition to class-action certification of another case, in Washington.

His reaction, he said, was that if the plaintiff’s attorneys had called him, he would have told them the resolution did not apply to their case.

Barr could not be reached for comment after repeated attempts.

* The doctors who served on the foundation’s medical advisory committee had relationships with the pharmaceutical industry, either by conducting clinical trials of new drugs or as company-paid consultants or speakers, Goldman said.

He said such relationships were good for the foundation, because doctors conducting clinical trials were able to get free medicine for patients who otherwise couldn’t afford it.

* When AIDS began to occur in hemophiliacs, there was debate within the foundation over how much information to share with the membership.

Aledort and some others argued that, since there was no treatment anyone could offer, “the NHF efforts to educate people were causing problems with patients in terms of irrational treatment decisions on the part of patients,” Goldman said.

On the other side of the argument were Goldman and the other lay members with hemophilia, who argued that the best way to prevent irrational behavior was “to provide accurate and timely information,” he said.

Aledort “believed that the NHF was spending too much time in dealing with the issues of AIDS and the safety of blood and blood supply, and believed that this was draining and inappropriate.”

* Early in his career, Goldman briefly represented a friend from New Jersey whose infant son had died from hepatitis after taking clotting concentrate. Goldman said he dropped the suit, filed against one of the clotting-drug manufacturers, because his friend did not have the money to pursue it, and

because the company’s attorney persuaded him he could not win.

The lawyer, he said, had told him that product contamination with hepatitis was unavoidable. Goldman said he believed that to be true at the time.

* Asked if he’d ever discussed the Wadleigh class action with any other judge, Goldman refused to answer and consulted with his attorney.

After a 10-minute recess, Goldman said he had never been consulted by any judge on that case or on a similar suit filed in New Jersey.

He acknowledged that last April, he’d commented on the issue of hemophilia and AIDS on Prodigy, a computer communications network.

His comments, he said, dealt with what the foundation could have done if it had known then what it knows now.

According to a transcript of the Prodigy comments, Goldman was asked his opinion of discussions between the foundation and the drug manufacturers, which had recently been completed.

Goldman wrote back that he believed “some people intentionally sabotaged any possibility of success by filing a class-action lawsuit just as results were forthcoming, but I may be wrong as I was only a peripheral observer.”

“As to whether NHF did all that could have been done,” he wrote, “my view is that I sleep very, very well at night, believing that we did all that we could.”

 

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Title: On The Trail Of Tainted Blood Hemophiliacs Say U.S.could Have Prevented Their Contracting Aids Trail of Tainted Blood

By: Donna Shaw

Date: April 16, 1995

Source: The Philadelphia Inquirer

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.

A 1976 government report on the problems of hemophilia therapy recited this U.S. Food and Drug Administration definition of safety for biologic products: ”Safety means the relative freedom from harmful effect to persons affected by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time.”

At a meeting in 1977, the World Federation of Hemophilia called on the makers of clotting concentrates to kill viruses in their products for the sake of “future generations of persons with hemophilia.” The organization repeated its message in 1979, urging more speed.

The federal government stood by its policy.

In July 1982, the U.S. Centers for Disease Control announced the first three AIDS cases in hemophiliacs.

There still were no heated clotting medicines sold in the United States.

One was available in Germany.

The U.S. firms, which knew of the German drug, were moving quickly to develop their own. A January 1983 internal Cutter memo urged speed in developing a heated product. It cited a projected loss of business should competitors get there more quickly.

The FDA approved the first heated clotting drug in March 1983. Made by Baxter, it was heated at 140 degrees Fahrenheit – as had been done with albumin since the 1940s – for 72 hours. Refinements in the heating process protected the clotting proteins.

In May 1983, another Cutter memo noted the company had been beaten to the marketplace. It called for a temporary solution “that will preserve our market position.”

In 1985, the FDA approved a solvent-detergent method of purging viruses

from plasma that had been developed by Bernard Horowitz and Alfred Prince of the New York Blood Center. Today, that method is considered a world standard.

In an interview, Horowitz said that researchers theoretically could have tried sooner to kill viruses in clotting medicines but that they had no way of knowing that AIDS was on the horizon.

“Keep in mind that virus killing isn’t new,” he said. “The thing was: Can you do it without killing the (clotting) protein? In 1980, it was considered a very difficult problem.”

As it turned out, he said, “it was less of a problem than predicted.”

Douglas Bell, a spokesman for the American Blood Resources Association, an industry group, said the task was far from simple. Besides figuring out the proper temperature and time, there were stabilizing compounds to be selected. Researchers also had to determine whether the body’s immune system would reject a heated clotting protein as a foreign invader, he said.

The testing required for government approval, first on animals and then on humans, was time-consuming.

“It took years to do all this work, as required by the FDA,” Bell said.

Thomas C. Drees says hepatitis was considered an unfortunate but unavoidable downside of the business. He was the first president of Alpha Therapeutic Corp., a Los Angeles maker of blood-clotting medicines.

In an interview, Drees, now a paid consultant for HIV-infected hemophiliacs, said that when he joined the industry in 1972, “it was sort of accepted that all of the workers in our plant were positive for hepatitis B, and so were all the hemophiliacs, and it was accepted that all the hemophiliacs would probably die of hepatitis at some time in their lives.”

One published study, performed by federal health researchers from 1968 to 1971 at an unidentified manufacturing company, concluded that hepatitis B was a common occurrence in plasma-industry workers. Similar studies already had been done at blood banks and hospitals.

The government study found that the most susceptible employees were those who performed “plasma dumping” – opening bottles and slashing open plastic bags of plasma and dumping the contents into larger containers. The unidentified company had a seniority policy that made it more likely that new workers would be assigned to plasma dumping, according to the study.

Drees said the U.S. government and industry reasoned that most hemophiliacs would live longer with the medicine than without it, making the risks worth the dangers.

In the 1970s, he said, heat-treating was not pursued with urgency since earlier experiments had shown that heat destroyed the clotting proteins’ potency.

“But when AIDS came on the scene . . . then they started heat-treating – and, son of a gun, it got rid of most of the AIDS,” Drees said.

Had the government demanded heating earlier to kill hepatitis B, he said, ”I think that would have saved the game” when AIDS erupted.

But officials at the FDA “tended to drag their feet” – and were too chummy with industry – he added.

The FDA declined comment.

Alpha spokesman Ed Colton called Drees a “renegade” who left the company in 1983 when his contract was not renewed. Colton termed Drees’ statement about hepatitis-exposed employees “a wild assumption” for which there was no evidence.

Even if some workers turned out to have the disease, “it may be unrelated to working” at the plant, Colton said. Citing ongoing litigation, he declined to respond to other questions.

Records from lawsuits filed by hemophiliacs show that Drees was not the only one who thought more could have been done in the 1970s. In a sworn February 1987 statement taken as part of a Kentucky lawsuit, Allen, by then retired as head of surgery at Stanford, spoke about his work with heat- treating.

“No medical, economic or social reason could justify ever using . . . unheated, pooled plasma or its clotting products,” he said. “Large pools are highly profitable, but they are medically bankrupt.”

In a deposition taken later that year for the same case, Allen said he first wrote to the Army about heat-treating plasma in 1940, a year before he started his Chicago study. He also said in the deposition that in about 1971, he urged a top industry official to heat his company’s clotting products.

In a 1993 deposition taken in a Missouri lawsuit, Charles M. Heldebrant, director of research and development for pharmaceuticals for Alpha, said his company never worked on killing viruses until mid-1982.

The directive to begin research on heat, he said, came from the marketing department, whose job was to keep up with competitors.

It took the Alpha scientists only about three or four months to develop a process, Heldebrant said. It involved heating at 140 degrees Fahrenheit for 20 hours.

Time and temperature were not the only issues. He said they also had to purify the concentrates further. As it turned out, he said, the purer product was easier to heat-treat.

During the deposition, a lawyer for an HIV-infected hemophiliac asked Heldebrant what technology he had used that could not have been developed years earlier.

“Absolutely nothing,” Heldebrant replied.

Alpha spokesman Colton, asked to comment on Heldebrant’s testimony, said the responses were only one small piece of the proceeding.

“It’s difficult for me to respond . . . when you are bent at looking at the 1 percent that entices you,” he said.

The amount of time it took to develop a heated product proved crucial

because heat, scientists were to learn, killed more than hepatitis. It also killed HIV – the virus that causes AIDS.

In fact, HIV was even more susceptible to heat than was hepatitis.

In 1993, a class-action lawsuit was filed in Chicago on behalf of all U.S. hemophiliacs who contracted the AIDS virus from clotting medicines. The suit’s central contention was that drug companies had sold HIV-tainted products even though they had reason to know that there were safe methods by which to cleanse them.

The defendants included the four U.S. companies that made clotting drugs in the late 1970s and early 1980s: Cutter and Hyland, whose labs processed plasma during World War II, and Alpha Therapeutic and Rhone-Poulenc Rorer Inc. of Collegeville, along with its Armour Pharmaceuticals subsidiary.

The fifth defendant was the National Hemophilia Foundation. The plaintiffs said the foundation was too financially dependent on the companies to be an effective advocate for hemophiliacs. The foundation denied that, insisting that it believed the products’ benefits had outweighed their risks.

Last month, a federal appeals panel threw out the class certification, saying the lawsuit might bankrupt the U.S. plasma-products industry, which has annual worldwide sales in excess of $2.4 billion. The case is proceeding with fewer plaintiffs and the decertification is being appealed.

The defendants deny any wrongdoing and are vigorously challenging the lawsuits. They say they acted promptly once the risk was known.

“We have people here who are really wringing their hands over all of this,” said Daniel McIntyre, a Miles Inc. spokesman. “They thought they were doing God’s work.”

William Mutert, vice president of marketing for Baxter’s Hyland division, recalled his anguish when, as a camp counselor for children with hemophilia, he learned that some boys had AIDS.

“It was really, really hard to see them,” he said, “after they were doing so well in the ’70s.”

The drug companies estimate that they have been named as defendants in 300 lawsuits involving 400 plaintiffs. Of the 13 cases in which verdicts have been returned, 11 have favored the companies. The one case they lost is under appeal. A new trial was recently ordered in the other case.

The companies have prevailed for a variety of reasons. Some plaintiffs have failed to sue within the time allowed by law. Other suits failed because most states, Pennsylvania and Delaware among them, have what is known as blood- shield laws. (New Jersey does not.) Those laws define blood-clotting drugs as services, not products, so, by definition, there can be no product liability.

The companies also have argued successfully that their manufacturing procedures met industry and government standards.

Before the class was decertified, the hemophiliacs rejected a partial settlement from Armour and Baxter, which offered up to $160 million. After all fees had been paid, that would have been about $25,000 per person.

As for government action, at least 17 other nations have set up programs to compensate HIV-infected hemophiliacs. In February, a U.S. representative from Florida introduced a bill in Congress that would pay $125,000 to each U.S. hemophiliac who contracted HIV from clotting medicines. Also eligible would be hemophiliacs’ infected spouses and children.

Today’s clotting drugs are considered much safer. Donors are screened, and their blood is tested. The products are heated or, more recently, treated with a detergent-solvent method designed to cleanse blood of such viruses as HIV and hepatitis B and C.

The newest, purest medicines are genetically engineered – but expensive – and some insurers are reluctant to pay for them.

Few hemophiliacs contracted HIV after the arrival of heated medicines, but the advances have not eliminated the possibility of contamination. Recent reports to doctors from the FDA and other researchers cite various plasma products – hemophilia medicines, albumin, and immune globulins – found to harbor hepatitis A, hepatitis C or parvovirus.

Albumin is used to treat shock, trauma and burns. It is also used during surgery. Immune globulins treat a variety of ailments, including measles, German measles, chicken pox, rabies, tetanus and smallpox.

“Future concern must turn to ‘new’ infections,” Roger Y. Dodd, head of the transmissible-diseases department of the American Red Cross, wrote in a paper presented at an international conference on viruses and blood held last October in Washington.

The conference ended with a panel discussion, during which one of the major topics raised was what the medical community would do when what one panelist dubbed the next “Martian virus” came out of nowhere and entered the blood supply.

Panelist James P. AuBuchon, head of the blood bank at Dartmouth-Hitchcock Medical Center, pointed out that solvent-detergent killed only viruses with a certain type of coating, known as lipid envelopes.

“There’s nothing to say the next AIDS-like virus . . . will have a lipid envelope,” he added.

There also have been reports from government and academic researchers of newly discovered viruses in blood, including a virus dubbed hepatitis G and an HIV strain not easily detected by tests. Hepatitis G has been found in patients around the globe.

Frank Kung, whose California company Genelabs Technologies Inc. collaborated with the government to identify hepatitis G, says the virus, like other bloodborne hepatitis, appears linked in severe cases to liver cancer and cirrhosis.

Is there a hepatitis H?

“We really do not know until we find the next one,” Kung said.

Even so, the government seems to have learned little from its failure to prevent the tragedy that has decimated the hemophilia community.

In December, the FDA’s Blood Products Advisory Committee declined to recommend the recall of products containing the plasma of two donors who later died from Creuzfeldt-Jakob disease.

An FDA official said the panel’s theory was that the products probably were too thoroughly processed and diluted for any of the abnormal protein that causes the rare, usually fatal, disease to survive.

The panel’s recommendation was denounced by the National Hemophilia Foundation and the Committee of Ten Thousand, a Boston-based activist group that spearheaded the class action and takes its name from the number of hemophiliacs infected with HIV.

Last month, the FDA asked the advisory committee to consider whether smaller plasma pools should be used for hemophilia medicines to reduce the risk. The committee recommended against it, primarily because of the higher cost. It voted for broadly worded virus-warning labels on plasma derivatives.

More than three years ago, the FDA asked manufacturers to virally

inactivate all plasma products. The agency issued a reminder a year ago. It has yet to be done.

An FDA spokesperson declined to comment for this article.

In 1993 testimony before a House subcommittee, FDA Commissioner David A. Kessler said that he believed his agency had erred in its relationship with the blood industry.

The FDA’s reliance upon voluntary compliance was “emblematic of our collegial approach to regulated industry at that time,” he said. “Those days are behind us.”

Kessler volunteered, though, that when his wife recently underwent surgery, she stored her own blood in advance – just in case.

 

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95 May Officials Dropped WarningTitle: Health Officials Dropped Warning For Hemophiliacs 

By: Donna Shaw

Date: May 23, 1995

Source: The Philadelphia Inquirer

As the AIDS virus was spreading through the nation’s blood supply in 1982, federal health officials deleted from an article a warning about the potential risks to hemophiliacs of tainted blood products, government documents show.

The warning, which said hemophiliacs “should be advised” of the possible risk of contracting AIDS from their clotting medicines, had been included in a Dec. 3, 1982, draft of the article, written by doctors at the U.S. Centers for Disease Control in Atlanta.

The draft was sent that same day to manufacturers of the hemophilia medicines, according to the government documents.

Seven days later, when the article was published in the Morbidity & Mortality Weekly Report, an influential government publication that is widely read by physicians and others, the warning for hemophiliacs was missing.

Before the first drug-maker began heat-treating its clotting medicines in 1983 to kill viruses, as many as 10,000 hemophiliacs in the United States contracted HIV, the AIDS virus, from the products, which are made from human blood plasma. Now, those people are dying of AIDS at the rate of one a day.

The omission of the warning came to light recently, when one of the article’s authors, the centers’ Dr. Bruce L. Evatt, was shown the two versions during sworn testimony in Washington.

“Do you know why it was omitted?” asked Robert L. Parks, an attorney for HIV-infected hemophiliacs who are suing the product manufacturers.

“I have no idea why it was omitted,” replied Evatt, who headed a CDC division investigating AIDS when he co-authored the article.

“When did you discover that that was omitted?” Parks said.

“Right now,” responded Evatt, now chief of the centers’ hematologic diseases branch within the Division of HIV/AIDS.

The centers’ spokeswoman, Michelle Bonds, said such articles normally are edited by the publication’s editorial staff, then move up through the chain of command to the director’s office for final approval.

“It’s hard to say at what level it was changed,” she said.

The agency’s legal office could not find “any indication or any information to lead us to why or how that information was deleted,” Bonds said.

Douglas Bell, a spokesman for the American Blood Resources Association, the industry group that represents the companies, said he could not comment

because of the continuing litigation.

Bayer Corp. spokesman Daniel J. McIntyre said the firm’s Cutter Biological subsidiary received the draft on Dec. 7, apparently as a courtesy.

“No response was requested, and none was offered by Cutter,” McIntyre wrote in response to a query from The Inquirer. “The company did not participate in the editorial process and does not know the procedures through which the text of the publication was determined.”

McIntyre said that until it became involved in the litigation, “the company was unaware that there was a difference in the text.”

Evatt said in his deposition that it wasn’t unusual for draft articles to be sent in advance to interested parties.

The Evatt deposition – taken at the Justice Department on March 29 and 30 as part of a federal lawsuit by HIV-infected hemophiliacs – marks the first time that the government has allowed any current officials to be deposed at length, on a wide range of questions, for the litigation.

Evatt said that by mid-1982, he and his staff strongly suspected AIDS was blood-borne. It didn’t take “a rocket scientist” to think this, he testified.

The draft by Evatt and his colleagues noted that several hemophiliacs who had used clotting medicines were diagnosed with AIDS. These reports of infection suggested that the disease posed a significant risk for hemophiliacs, the article said. Then came the warning that was deleted: ”Patients receiving therapy should be advised of that possible risk.”

Evatt also recounted conversations he had in 1982 with another AIDS researcher then at the centers, Dr. Donald Francis.

In those conversations, Evatt said that except in life-threatening situations, he would not treat his own son with the clotting drugs if his son were a hemophiliac, according to his testimony.

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Rift

Title: At Annual Meeting, Hoping To Heal Hemophiliacs’ Rift

By: Donna Shaw

Date: October 12, 1995

Source: The Philadelphia Inquirer

There is much that keeps Michael Carlin alive in the memories of his family.

There is his poetry. His music. And there is his mother, Fern Carlin, a woman determined to see something positive come from the loss of her only child.

“The first thing I had to deal with was that I wanted to die,” said Fern Carlin, of Fort Washington. “I had to figure out, why would I be here for no reason? . . . It was like I’d been catapulted to another planet.”

“Then I turned around one day and realized that I was starting to look like grief. I realized I wasn’t going to kill myself, so I’ve got to make my life as good as possible. So I joined a cause.”

Across the United States, there are thousands like Carlin – mothers, fathers, wives and other loved ones of hemophiliacs who in the late 1970s and early 1980s contracted the AIDS virus from commercial blood-clotting medicines.

Today, they and hundreds of others affected by the inherited bleeding disorder are in Philadelphia for the start of the annual meeting of the National Hemophilia Foundation.

As it has been in recent years, the meeting likely will have its share of discord. Hemophiliacs are a community divided, between those who got the virus and want retribution, and those who believe it couldn’t be helped and want to move on.

A dissident organization, The Committee of Ten Thousand (named for the number of U.S. hemophiliacs believed to be infected), now competes with the foundation to be the group’s primary representative. COTT blames the foundation in part for the AIDS tragedy and has named it as a defendant in some lawsuits, saying the foundation was little more than a marketing arm for

drug makers in the crucial early period of the AIDS crisis.

In recent months, there have been attempts to heal the rift between the two groups. Both organizations, for example, are working for congressional approval of the Ricky Ray Hemophilia Relief Fund Act, a bill that would establish a $1 billion fund to compensate hemophiliacs whose blood-clotting medicines infected them with the AIDS virus. Each infected person would get a one-time lump sum of $125,000. Ricky Ray was the Florida teenager who died in 1992 after contracting AIDS from the medicine.

Still, the chasm is wide. While COTT members will attend the foundation’s convention, being held at Wyndham Franklin Plaza Hotel, COTT president Jonathan Wadleigh said his group also would hold a separate meeting in a church across the street.

Carlin is somewhere in the middle. She works part time now for the foundation’s local chapter in Glenside – but is adamant that someone will answer for the tragedy that a recent government-funded report blamed upon “a failure of leadership.”

Carlin’s son died in a coma, of AIDS-related complications, in 1993 at the age of 28.

David Krugman, 28, an Abington hemophiliac who got AIDS from clotting medicines, wants some answers, too.

Krugman, like Michael Carlin an only child, was just embarking on a career as a writer when stricken by the disease. Now he’s unable to work but spends hours at his computer and on the telephone, lobbying for the Ricky Ray bill.

Until recently, he feared to tell people about his disease and how he got it.

“Most people don’t care how I got it,” he said. “They say I deserve to die. They’ve actually said this to me on-line.”

Krugman lives with his mother and hopes for the best when it comes to the legislation and the lawsuits.

“I’m the last in line on both sides of my family,” he said. “I see my friends settling down and having children, but I’ll never have a wife or children. The government and the (drug( companies can’t just say ‘oops’ to that.”

Fern Carlin still vividly remembers her son’s first serious bleeding episode. It was in 1965, when he was a year old.

Michael cried nearly nonstop for 36 hours, and at first his frantic family didn’t understand what was wrong. The bleeding was inside a knee joint, where no one could see.

Later, standing at Michael’s bedside in St. Christopher’s Hospital for Children, Carlin was stunned at the enormity of her child’s pain. It tore her apart to think that he was doomed to suffer these excruciating bleeds for the rest of his life – and that the 2-month-old life she carried inside her might be a hemophiliac or a carrier, too. The genetic defect runs in families, the doctors had told her, but no one else in her family had had it.

So, Carlin said, she had a talk with God:

“This is my first child, and I love him dearly, but I don’t want to do this to another baby. I’ll love this new baby either way, but I’m leaving it up to you.”

Within hours, she had a miscarriage. Carlin had her tubes tied after that.

Now, Carlin says, she’s no longer at war with herself. She’s even ready to get back into a career, something she’d forsaken when her son’s illness overtook them.

“I can channel the anger, and that’s so important,” she said. “This feeling of being a victim, of being robbed, will just take you over completely if you let it.

“I would really like to make the absolute most of the rest of my life, to make it positive for myself and others. The last thing Michael said to me was, ‘Be kind. Be now. Don’t cry. We did good.’ So this is what I have to believe in.”

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Blood safety changes ordered

Title: Blood Safety Changes Ordered

By: Donna Shaw

Date: October 13, 1995

Source: The Philadelphia Inquirer

Vowing that government would never again allow an AIDS-style tragedy to kill thousands of transfusion recipients, Secretary of Health and Human Services Donna Shalala yesterday ordered sweeping changes in the way the nation regulates blood safety.

Shalala announced she had appointed a blood-safety director to oversee and coordinate all Public Health Service programs on blood. The lack of a single administrator with authority to make decisions was a key factor in the government’s slow response to suspicions in the early 1980s that the AIDS virus had infected the blood supply, she said.

She also announced that the Food and Drug Administration’s Blood Products Advisory Committee no longer would have any voting members from industry or even members with “the appearance of a conflict of interest resulting from their connection to the blood industry.” Industry members will be nonvoting advisers to the committee, Shalala said.

“Blood safety must never again be handled as a secondary issue,” she said in testimony before a House subcommittee. “I am elevating it to the highest level of the department.”

Shalala named Dr. Philip Lee, the HHS assistant secretary for health, as her blood-safety director.

She also created a blood-safety committee to assist Lee; it will include the heads of the FDA, the National Institutes of Health, and the Centers for Disease Control and Prevention.

Shalala’s moves received cautious praise from hemophilia activists and doctors who also testified at the hearing, which was held by a subcommittee of the House Committee on Government Reform and Oversight. But they cautioned that the new measures would be effective only if industry was not permitted to dominate Lee’s safety panel.

“Our big concern is if we’re going to set up a council that mimics what we’ve seen in the past,” said Corey Dubin, a California hemophilia activist who contracted the AIDS virus and hepatitis from blood-clotting products.

In the late 1970s and early 1980s, between 8,000 and 10,000 hemophiliacs were infected with the AIDS virus from tainted blood products. An additional 12,000 people received HIV-infected blood transfusions.

An unknown additional number – so poorly defined and studied that officials could put it only at somewhere between 100,000 and 200,000 – are believed infected with Hepatitis C from blood and plasma products. There is little that doctors can do to treat or cure such patients, and treatments intended to

inactivate viruses don’t always work, the officials said.

Shalala’s moves were the latest in a series of reforms in response to a July report by the Institute of Medicine (IOM) blaming government regulators for not taking stronger action in the early 1980s to prevent thousands of deaths from HIV-tainted blood products. The report also was sharply critical of the plasma-products industry, which makes hemophilia-clotting medicines and other plasma products.

Echoing the findings of that report, Shalala said a “lack of leadership” in the early 1980s contributed to the problems and that “some key political leaders were openly hostile” to intervention because the first victims were gay.

“It is clear that the history is a sorry history that we do not want to repeat,” she said.

The American Blood Resources Association, which represents the plasma- products industry, said in a statement yesterday that it supported “in principle” many of the institute’s recommendations.

“At the same time, we must make clear that many of IOM’s ‘findings and conclusions’ are incorrect and without foundation,” the group said in a prepared statement.

The FDA Blood Products Advisory Committee, long dominated by experts with industry ties, has been a particular target of criticism from hemophilia activists.

For example, at its last meeting, held in June, the panel agreed unanimously that a new HIV blood-screening test was more effective than previous versions. But in a subsequent vote after heated debate, it refused to recommend that the test be required to screen blood donors at blood and plasma collection centers, deciding that the public-health benefit did not justify the expense.

The committee was disbanded soon afterward and, in August, FDA Commissioner David A. Kessler rejected its advice on the screening test. He also overruled it on another issue, saying the FDA would recommend the recall of any blood products that might contain the rare, but fatal, Creutzfeldt-Jakob disease.

Shalala said that when the committee is re-formed, it will have more consumer representation and a permanent member from the Centers for Disease Control, the agency that was ignored when it sounded the first alarm on AIDS and blood in the early 1980s.

Lee said his blood-safety committee would look at broader ethical and social-policy issues involved in maintaining an adequate blood supply and, thus, not conflict with the FDA advisory panel, whose function is to advise regulators.

Asked if she endorsed the Ricky Ray Hemophilia Relief Fund Act, a bill that would provide financial compensdation to HIV-infected hemophiliacs, Shalala said HHS officials “have not reviewed that issue.” But she and Lee said they would be willing to talk to Congress about it.

In Philadelphia last night, at the opening of the National Hemophilia Foundation’s annual meeting, the crowd applauded noisily when told that the Ricky Ray bill had gained 135 co-sponsors in the House. It needs 218 to be brought to the floor for a vote.

 

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Maker to pay Japanese victims

Title: Maker Of HIV-Tainted Drug To Pay Its Japanese Victims

By: Donna Shaw

Date: February 27, 1996

Source: The Philadelphia Inquirer 

A U.S. company whose blood-clotting medicines infected thousands of hemophiliacs worldwide with the AIDS virus has agreed to pay compensation to the victims in Japan.

The out-of-court settlement was reached yesterday during a meeting between Vernon R. Loucks Jr., chairman of Baxter International Inc., and Naoto Kan, Japan’s health and welfare minister, according to officials representing both sides.

“We think settlement is the best option,” said Mary Thomas, a spokeswoman at Baxter’s headquarters in Deerfield, Ill.

Said Eric Weinberg, a New Jersey lawyer who represents a group of HIV-infected hemophiliacs in the United States: “I think it’s a good thing that the Japanese hemophiliacs are getting some justice. It would be nice to say that the same thing has happened here.”

Should the settlement be completed, Japan would become the 23d nation in which compensation – either from government, industry or both – has been paid to HIV-infected hemophiliacs, according to the World Federation of Hemophilia. The United States – whose estimated 8,000 to 10,000 HIV-infected hemophiliacs represent the largest toll in the world – is not among them.

Bills have been introduced in Congress that would set up a $1 billion fund, or about $125,000 per hemophiliac. Hundreds of lawsuits are pending in federal and state courts.

Thomas said the Japanese Health Ministry and Baxter would take “a leadership role” in negotiating the deal in Japan, with the money to come from the government and five drug companies, including Baxter.

“It’s very, very good news,” said Masami Kobayashi, a San Francisco activist who works on behalf of Japanese hemophiliacs.

In Japan, about 373 lawsuits have been filed by HIV-infected hemophiliacs. Thomas said a settlement there would include not only that group, but all of Japan’s infected hemophiliacs. Activists put the number at 2,000 people, of which 400 have died.

The pressure in Japan for a settlement has been strong since October, when two Japanese courts urged the government and industry to acknowledge their roles in the incident and pay at least $420,000 to each victim. The courts suggested that government pay 40 percent and industry 60 percent.

Japan’s government recently expressed regret for failing to protect its citizens from contaminated blood products. In the late 1970s and early 1980s, thousands of hemophiliacs worldwide contracted the AIDS virus from clotting drugs, which are made from human plasma.

In testimony in 1994 before a U.S. scientific panel in Washington, the Hemophilia Federation of Japan blamed clotting medicines imported from the United States, as well as HIV-laden plasma collected here and sold to Japanese drug firms.

Speaking in halting English, one Japanese mother who testified in Washington, Etsuko Kawada, told of how she and her 18-year-old hemophilic son had hidden for years his HIV-positive status. Until recently, Japanese hemophiliacs with AIDS rarely went public, citing the stigma attached to the disease.

“While my son is still with me in this world, this mother feels responsible to find out about the truth of what happened,” Kawada told the Institute of Medicine panel.

As the Japanese public has grown to understand what befell the hemophiliacs, it has rallied to their cause, led by college students and other groups, according to Kobayashi, the Japanese activist. Unlike in the United States, where safer, heat-treated clotting drugs were available in 1983, Japan was much slower to respond to AIDS. Medicines that were heated to kill HIV weren’t available in Japan until 1985.

The Inquirer reported last year that Baxter, which was the first company to sell heated clotting drugs in the United States, did not expedite its virus-killing research until after it learned of competition from a German company.

Even after Baxter began developing a heat-treated product, documents show the company targeted Germany as its most important market. Although Germany had far fewer hemophiliacs than the United States, clotting drugs commanded a higher price there.

An internal Baxter memo dated Jan. 11, 1982, spelled out these priorities: Germany was viewed as the most important market for a safer medicine, followed by the United States and Japan.

Baxter has denied having a priority system such as the one described in the memo. It has also said that it tried to sell the heated medicine in Japan sooner, but was stalled by regulators.

In 1994, Baxter and Rhone-Poulenc Rorer Inc., of Collegeville, offered a combined $160 million to HIV-infected hemophiliacs in the United States. The offer, which after legal fees would have paid less than $30,000 per person, was rejected as too low. Two other companies involved in the U.S. litigation – Alpha Therapeutic Corp., of Los Angeles, and Germany’s Bayer Corp. – did not participate in the offer.

Other than Baxter, the companies expected to take part in the Japanese settlement are Bayer Yakuhin Ltd., Bayer’s Japanese subsidiary, and three Japanese companies: Alpha’s parent company, Green Cross Corp.; Chemo-Sero-Therapeutic Research Institute; and Nippon Zoki Pharmaceutical Co.

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Settlement Offer

Title: Settlement Offer In Hemophiliac Suit Raises Painful Questions 

By: Donna Shaw

Date: April 21, 1996

Source: The Philadelphia Inquirer 

Petra Jason got the call from her ex-husband on Nov. 2, 1983, at her home in Miami. He was hysterical and barely coherent.

A donor of the blood plasma used to make their son Bradley’s clotting medicine was believed to have AIDS, he said. Did she have any unused bottles from Lot No. NC8477?

Jason rushed to her kitchen junk drawer, where she kept the box tops from the medicine Brad, 11, had already used. There she found a box top stamped NC8477. Then, five more just like it.

“After I found the one, I knew my son was going to die,” she said.

Bradley, a hemophiliac and Jason’s only son, developed AIDS and died in January 1992, after one semester at Tulane University, where he had earned four A’s and two B’s before illness forced him home.

Now, she has until May 20 to make some decisions.

Is a settlement of about $100,000 – maybe more, maybe less, depending on the number who apply – worth dropping legal action against the medicine’s manufacturers?

Will ending the years-long effort help her move on with her life?

* Across the nation, thousands of HIV-infected hemophiliacs and their loved ones are facing the same industry-imposed deadline.

On Thursday, four pharmaceutical companies whose products transmitted the AIDS virus to an estimated 8,000 to 10,000 U.S. hemophiliacs announced what they called a nonnegotiable proposed settlement of $600 million. The money would be divided equally among the claimants.

The companies – Germany’s Bayer AG; Baxter Healthcare Corp., of Deerfield, Ill.; Alpha Therapeutic Corp., a Los Angeles subsidiary of a Japanese firm; and Rhone-Poulenc Rorer Inc., of Collegeville – would admit no liability.

And, if more than 100 people refuse the deal and continue suing the companies, the offer will be withdrawn.  “At least 95 percent” of all those who are suing must accept the deal, according to a letter sent Friday by the companies to plaintiffs’ attorneys.

Hemophilia activists say that stipulation could doom the settlement, which also sets aside $40 million for legal fees. Even more, they fear the issue will divide their community, pitting those who are willing to take their chances in court against those who desperately need the money now, or simply want to put the tragedy behind them.

The hemophiliacs, moreover, are in an unusual situation. Most continue to use the companies’ blood-clotting products and would like to rebuild a working relationship with the industry upon which so many lives depend.

“I guess the question is, how much value is in a human life? Is my life worth what one low-paid executive makes in a year?” said David Krugman, an Abington Township hemophiliac who contracted the AIDS virus from clotting drugs in the late 1970s.

Krugman’s soaring medical bills and inability to work meant he had to move back in with his mother and accept Medicaid. He said he would consult with his lawyers for advice on what to do. He isn’t sure, for example, if accepting the money would disqualify him for continued Medicaid assistance.

“I do need money now,” he said. “Seven figures would be nice, but if it comes through after I’ve been dead for two or three years, what use is it?”

A Radnor woman whose 22-year-old son with hemophilia and AIDS died in September says the dollar amount doesn’t matter. She never sued over her son’s death and sees a settlement as an opportunity to set up a scholarship in his name.

“I’m just glad some culpability is being established,” said the woman, who asked not to be identified. “There has to be some responsibility; you do something wrong, you own up to it.”

For Ethel Livingston, a Baltimore-area woman who lost three sons, a brother and a daughter-in-law to hemophilia-related AIDS, it took  “all of two minutes” to decide that the offer wasn’t enough.

“Yes, I could really use it, but it’s a slap in the face,” said Livingston, who said her family’s medical needs left her destitute.

She contrasted the offer to what the industry and the government jointly agreed to pay in Japan just a month ago – $430,000 per person plus monthly stipends for life. The government paid 44 percent of the cost.

But Livingston said other family members were considering the industry offer, to help pay the costs of raising her dead sons’ children.

Meanwhile, legislation that would provide $1 billion in government compensation for HIV-infected hemophiliacs gained new supporters in Congress. A spokeswoman for Rep. Porter Goss (R., Fla.), the bill’s sponsor in the House, said Friday that the measure had 225 cosponsors – 218 is a majority of Congress – and that more legislators were calling for information since hearing about the proposed settlement.

* At a news conference Friday, Goss and Sen. Mike DeWine (R., Ohio) called the companies’ settlement offer

Petra Jason got the call from her ex-husband on Nov. 2, 1983, at her home in Miami. He was hysterical and barely coherent.

A donor of the blood plasma used to make their son Bradley’s clotting medicine was believed to have AIDS, he said. Did she have any unused bottles from Lot No. NC8477?

Jason rushed to her kitchen junk drawer, where she kept the box tops from the medicine Brad, 11, had already used. There she found a box top stamped NC8477. Then, five more just like it.

“After I found the one, I knew my son was going to die,” she said.

Bradley, a hemophiliac and Jason’s only son, developed AIDS and died in January 1992, after one semester at Tulane University, where he had earned four A’s and two B’s before illness forced him home.

Now, she has until May 20 to make some decisions.

Is a settlement of about $100,000 – maybe more, maybe less, depending on the number who apply – worth dropping legal action against the medicine’s manufacturers?

Will ending the years-long effort help her move on with her life?

* Across the nation, thousands of HIV-infected hemophiliacs and their loved ones are facing the same industry-imposed deadline.

On Thursday, four pharmaceutical companies whose products transmitted the AIDS virus to an estimated 8,000 to 10,000 U.S. hemophiliacs announced what they called a nonnegotiable proposed settlement of $600 million. The money would be divided equally among the claimants.

The companies – Germany’s Bayer AG; Baxter Healthcare Corp., of Deerfield, Ill.; Alpha Therapeutic Corp., a Los Angeles subsidiary of a Japanese firm; and Rhone-Poulenc Rorer Inc., of Collegeville – would admit no liability.

And, if more than 100 people refuse the deal and continue suing the companies, the offer will be withdrawn. “At least 95 percent” of all those who are suing must accept the deal, according to a letter sent Friday by the companies to plaintiffs’ attorneys.

Hemophilia activists say that stipulation could doom the settlement, which also sets aside $40 million for legal fees. Even more, they fear the issue will divide their community, pitting those who are willing to take their chances in court against those who desperately need the money now, or simply want to put the tragedy behind them.

The hemophiliacs, moreover, are in an unusual situation. Most continue to use the companies’ blood-clotting products and would like to rebuild a working relationship with the industry upon which so many lives depend.

“I guess the question is, how much value is in a human life? Is my life worth what one low-paid executive makes in a year?” said David Krugman, an Abington Township hemophiliac who contracted the AIDS virus from clotting drugs in the late 1970s.

Krugman’s soaring medical bills and inability to work meant he had to move back in with his mother and accept Medicaid. He said he would consult with his lawyers for advice on what to do. He isn’t sure, for example, if accepting the money would disqualify him for continued Medicaid assistance.

“I do need money now,” he said. “Seven figures would be nice, but if it comes through after I’ve been dead for two or three years, what use is it?”

A Radnor woman whose 22-year-old son with hemophilia and AIDS died in September says the dollar amount doesn’t matter. She never sued over her son’s death and sees a settlement as an opportunity to set up a scholarship in his name.

“I’m just glad some culpability is being established,” said the woman, who asked not to be identified. “There has to be some responsibility; you do something wrong, you own up to it.”

For Ethel Livingston, a Baltimore-area woman who lost three sons, a brother and a daughter-in-law to hemophilia-related AIDS, it took “all of two minutes” to decide that the offer wasn’t enough.

“Yes, I could really use it, but it’s a slap in the face,” said Livingston, who said her family’s medical needs left her destitute.

She contrasted the offer to what the industry and the government jointly agreed to pay in Japan just a month ago – $430,000 per person plus monthly stipends for life. The government paid 44 percent of the cost.

But Livingston said other family members were considering the industry offer, to help pay the costs of raising her dead sons’ children.

Meanwhile, legislation that would provide $1 billion in government compensation for HIV-infected hemophiliacs gained new supporters in Congress. A spokeswoman for Rep. Porter Goss (R., Fla.), the bill’s sponsor in the House, said Friday that the measure had 225 cosponsors – 218 is a majority of Congress – and that more legislators were calling for information since hearing about the proposed settlement.

* At a news conference Friday, Goss and Sen. Mike DeWine (R., Ohio) called the companies’ settlement offer “a giant first step” but said it should not take the place of federal compensation. The government, they said, failed to respond to the AIDS threat and take proper regulatory action.

Petra Jason, for her part, has made up her mind.

“I think about what it was like to hear my child’s last breath, and that this Mother’s Day I’m going to look at his name on a piece of black granite in the ground,” she said.

“Will I take the money? Never.”

a giant first step” but said it should not take the place of federal compensation. The government, they said, failed to respond to the AIDS threat and take proper regulatory action.

Petra Jason, for her part, has made up her mind.

“I think about what it was like to hear my child’s last breath, and that this Mother’s Day I’m going to look at his name on a piece of black granite in the ground,” she said.

“Will I take the money? Never.”

__________________________________________

Offer to be rejected in HIV case-Pg.1.jpegTitle: Offer To Be Rejected in HIV Case

By: Donna Shaw

Date: May 13, 1996

Source: The Philadelphia Inquirer 

Leaders of HIV-infected hemophiliacs intend to reject a $640 million settlement offer as too low, and have scheduled new talks today in Philadelphia with four drug companies whose blood-clotting products infected thousands of people with the AIDS virus.

Last month, the four companies offered $600 million plus $40 million in legal costs to settle most claims brought by the estimated 8,000 to 10,000 U.S. hemophiliacs who contracted HIV from clotting medicines in the late 1970s and early 1980s. But leaders of the hemophilia community say that’s not enough.

They say new evidence shows that, as AIDS was emerging in the blood supply, some companies were making clotting products from plasma that included donations from people known to have suffered from another blood-transmissible virus, hepatitis. And, they say, the government did nothing to stop the practice, even though it violated federal drug-safety regulations.

“It would be like recruiting British cows for products even though you knew about mad cow disease,” said Charles Kozak, an attorney for the hemophiliacs.

In rejecting the agreement, the American hemophiliacs question why they should settle for less than hemophiliacs in Japan. In March, the Japanese government and the drug industry, including three of the four companies involved in today’s talks, agreed to pay about $420,000, plus monthly stipends for life, to each of the 1,800 Japanese hemophiliacs who contracted HIV from blood-clotting products. The Japanese government is paying 44 percent of the total.

“Why should the life of an American hemophiliac be worth less than the life of a Japanese hemophiliac?” asks Corey Dubin, a Californian who is president of the Committee of Ten Thousand, an activist group for HIV-infected hemophiliacs. He will be one of the key negotiators at today’s meeting.

The new evidence cited by the hemophiliacs, acquired through court proceedings, also shows that the Food and Drug Administration gave advance notice before conducting some safety inspections at blood- and plasma-collection centers, which supplied the drug makers. Today, that policy is still in effect.

The advance-notification policy drew harsh complaints from one FDA enforcement official, who wrote in a 1982 internal agency memo that the policy allowed “sloppy or corrupt” plasma-collection centers “to clean up and cover up.” The memo was written two months before government scientists began issuing written warnings that the AIDS virus might be transmitted through plasma-based hemophilia medicines.

Even before the advent of AIDS, many hemophiliacs already had contracted liver disease from various forms of hepatitis contained in clotting products. The hemophiliacs say the companies should have worked faster to develop untainted versions of the drugs.

The plasma-products industry says it acted as quickly as possible to cleanse the drugs once it realized they were transmitting HIV to hemophiliacs, who have an inherited clotting disorder. The FDA approved the first clotting products that were heated to kill viruses in 1983, 15 years after the medicines were first developed.

Expected to participate in today’s meeting at a Center City hotel are lawyers David Shrager and Wayne Spivey of Philadelphia, who serve as lead plaintiffs’ counsel for hundreds of hemophilia cases filed in federal courts; representatives of HIV-infected hemophiliacs; and representatives of four drug companies: Rhone-Poulenc Rorer Inc. of Collegeville; Baxter Healthcare Corp. of suburban Chicago; Germany’s Bayer AG; and Alpha Therapeutic Corp., the Los Angeles subsidiary of Japan’s Green Cross Corp.

According to drug-company documents produced in the hemophilia litigation, plasma collected from gay men, prison inmates and others with a history of hepatitis B was among the plasma being used to make hemophilia medicines, at least until questions about the practice were raised in 1982.

FDA regulations required that donors be “in good health” and free from “a history of viral hepatitis.”

Why, then, was the plasma from these donors even collected?

The donors were recruited because they had been exposed to hepatitis B, making their plasma a rich source of antibodies that could be used for immune globulin and diagnostic products, and for research.

But the hemophiliacs contend that this plasma should not have been added to the pools used to make clotting drugs. The plasma, they say, was from donors at high risk not only for hepatitis, but also for a variety of other infections, including what would come to be known as HIV.

In telephone interviews last week, Jay S. Epstein, director of the FDA’s Office of Blood Research and Review, said that in the early 1980s, the FDA “was well aware” that plasma from hepatitis-antibody donors was being used in the manufacture of hemophilia medicines. The prevailing theory at the time, he said, was that it was a good idea to have infection-fighting antibodies in the plasma pools.

Epstein said that even though the presence of hepatitis B antibodies proved that a donor once was infected with the virus, the use of such plasma for hemophilia medicines was not deemed a violation of FDA regulations – as long as the donor answered “no” when asked if he’d ever had symptoms of hepatitis. Most of these donors were paid.

The FDA interpreted “a history of viral hepatitis” as meaning a person who had actually been jaundiced and had felt sick, not a symptomless case, he said.

“You can argue that it wasn’t wise,” Epstein said. “But to argue that it was violative is inaccurate. That doesn’t mean that people couldn’t have done better.”

At the time, two of the four drug manufacturers were using some hepatitis-antibody plasma for hemophilia medicines, court documents indicate.

In a December 1982 letter to the National Hemophilia Foundation, Michael Rodell, vice president of regulatory affairs and quality control for Baxter’s Hyland division, said his company “within the past several months” had made a commitment to end the practice.

He added, though, that he could not say what types of donors were being accepted at whole-blood collection centers – a “significant” source of plasma used by Hyland and other companies.

An August 1982 memo written by John Hink, then director of plasma procurement for the Cutter division of what now is Bayer AG, stated that “until recently,” Cutter’s hepatitis-antibody plasma “(all collected from centers dealing predominantly with homosexuals) has been used in the manufacture of coagulation products.”

Hink wrote that Dennis Donohue, an FDA liaison with the plasma-products industry, had asked the company “to voluntarily exclude plasma collected from known homosexuals from pools used in the production” of hemophilia medicines.

Hink said that at a forthcoming company meeting, he would recommend that Cutter agree to a temporary exclusion of “plasma collected from centers dealing primarily with known homosexuals or donors with a history of hepatitis.”

In response to a request for comment, Bayer said Hink had testified during a deposition last year that he was incorrect in the assertions made in his memo.

“Subsequent to that memo’s writing, Mr. Hink was able to confirm that, in fact, such plasma was not being used in the manufacture of coagulation products, but rather was used to manufacture hyper-immune products,” Bayer said in a statement.

Another Cutter memo, this one written in December 1982 by Steven J. Ojala, director of regulatory affairs, described a meeting with the drug industry in which the FDA’s Donohue asked “if we were willing to exclude plasma collected at prisons,” where inmates were hyper-immunized – that is, injected with infective material to boost their antibody levels.

“The other manufacturers had no problem with this suggestion,” Ojala wrote, “but it was pointed out that this was the source of our hyper-immunized donors. Donahue then suggested that we exclude this plasma” from hemophilia drugs.

Donohue has retired and could not be reached for comment. But in testimony he gave as part of the hemophilia litigation in 1992, he said it was “impossible” during the early 1980s to change laws regarding donor selection and plasma collection, “because of the regulatory climate within the Reagan administration.”

And what of the FDA’s advance-notification policy for inspections at blood centers, which drew the ire of the agency’s own counsel?

It’s still in effect today, according to FDA Deputy Commissioner Mary Pendergast. But she said the advance notice is given primarily for pre-licensing, and not routine, inspections.

Advance notification ensures that someone in charge will be present if the center isn’t yet in operation, she said.

In a May 1982 memo, Robert M. Spiller Jr., an FDA associate chief counsel for enforcement, urged that the policy be changed. At the time, he was helping prosecute several plasma-center operators.

Spiller said employees from the centers had told investigators that when they learned of an impending FDA inspection, they would rewrite or even destroy incriminating rec-ords and clean up the premises.

Pendergast said she thought those concerns were legitimate. She added, “I think we’ve done a lot to make our blood inspection program much more rigorous,” including using better-trained inspectors.”

“If you look at what happens now,” she said, “it’s different than what we did in 1981 and ’82.”

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ruins

Title: Bad Blood Has Left Her Life In Ruins

By: Donna Shaw

Date: June 20, 1996

Source: The Philadelphia Inquirer 

This isn’t how life was supposed to turn out for Judith Trullinger.

She was smart and attractive, witty and fun-loving, a Drexel grad who studied to be a teacher. She should have had a good job, a loving family, a secure home.

Tainted blood robbed her of all three.

In 1992, AIDS claimed her only child, Mark. A hemophiliac, he had been infected with the virus by tainted blood-clotting medicines. So was Trullinger’s father, Sherman, a hemophiliac who died in 1985 after a series of strokes.

Alone and severely depressed by their deaths, Trullinger tried to distract herself by holding two jobs. It didn’t help. She had a breakdown, became suicidal, and couldn’t work.

Now, deeply in debt, her disability benefits exhausted, with congressmen and social-service agencies saying they cannot help, Trullinger is about to lose her home, a small rowhouse in Colwyn, Delaware County. A sheriff’s sale is scheduled for 11 a.m. tomorrow.

“I’ve got no place to go but my car. No family. I’ve written to everyone on the face of the earth, and they say I don’t fit into any program, that I fall through the cracks in the system,” said Trullinger, 53, who likens her disheveled existence to that of a “bag lady.”

“They say I’m not elderly, I’m not sick enough, I’m not out of touch with reality. They tell me that because I understand my son should not have died, I’m sane.”

There’s more.

Under terms of a proposed $640 million settlement being worked out between four pharmaceutical companies and lawyers for thousands of HIV-infected hemophiliacs nationwide, Trullinger could be eligible to receive $100,000 soon – perhaps $200,000 if she can prove her father’s death was, like her son’s, a result of HIV-tainted clotting medicines.

But that might not help her: Should she decide to accept the settlement rather than pursue a lawsuit, the government could take the money to repay income taxes they estimate she owes.

The government also might deny her potential benefits such as Medicaid, which is based on financial need, until what’s left of her share is exhausted.

“It’s like the government wants me to pay them for killing my son,” Trullinger said angrily, pointing to an Institute of Medicine report issued last year that blamed “a failure of leadership” among federal health officials and others for the HIV infection of up to 10,000 U.S. hemophiliacs.

Indeed, the entire settlement proposal could collapse because of the benefits issue, since many HIV-positive hemophiliacs, unable to work and their resources depleted, rely on one or more sources of public assistance. The medical bills of a hemophiliac with AIDS can exceed $100,000 per year.

David Shrager, the Philadelphia lawyer who is lead attorney in the consolidated federal cases brought by HIV-infected hemophiliacs, said it would be “worse than ironic” for the government to deny benefits or seek reimbursement from hemophiliacs taking part in the settlement. He said lawyers for both sides were working hard to find a solution quickly.

“I will not support this settlement if the money the people get is not the money they get to keep,” he said.

The lawyers and hemophilia activists have suggested several possible solutions. Among them: a federal judge ordering the government to keep its hands off the money, or an agreement by federal regulators to waive any leins.

Another potential answer, activists say, would be to amend the Ricky Ray Hemophilia Relief Fund Act, a bill that would establish a government compensation fund for HIV-infected hemophiliacs. Sponsored by U.S. Rep. Porter Goss (R., Fla.), the bill, as of last week, had 241 co-sponsors – more than half of Congress – but has not been scheduled for a vote.

The Ricky Ray bill contains language that forbids any federal compensation from being counted as income “for purposes of determining the eligibility of the individual to receive benefits,” saying that the government “failed to fulfill its responsibility to properly regulate the blood-products industry.”

Trullinger, meanwhile, has more immediate problems. First, there’s tomorrow’s sheriff’s sale of her house. Then, there’s the $145,000 that the Internal Revenue Service estimates she owes for seven years’ worth of taxes, based on prior earnings. The IRS contends she failed to file her returns.

Trullinger says she filed, but can’t bring herself to search for records that are probably in some of the cardboard boxes cluttering her home. Those boxes, she says, contain too many memories of Mark. She keeps his ashes upstairs, in his bedroom.

Her marriage broke up soon after Mark was born in 1972. Her husband, Trullinger says, couldn’t deal with hospitals and what lay ahead for their son.

As a newborn, Mark bled profusely after circumcision. Doctors discovered he had hemophilia. Mark had inherited the genetic bleeding disorder from his mother, who hadn’t known she carried the trait. Her father, Trullinger soon learned, was a hemophiliac, but had kept it quiet.

Mark died at the age of 20 after a vain effort to finish his studies at Delaware County Community College. A good student who had earned a scholarship and several community awards, Mark wanted to go into communications, perhaps as a broadcast journalist.

In a videotaped interview with a hospital psychiatrist shortly before he died, Mark spoke bitterly of his shortened life, and the career he would never know. But for his mother, he had nothing but love and admiration.

He recalled a time when authorities accused Judith Trullinger of child abuse and neglect because she refused to bring Mark to the hospital for treatment every week between 9 a.m. and 5 p.m. – her work hours. She asked for extended hours that better suited a single, working parent, but they refused, he said.

“She sacrificed everything for me . . . things she could have had . . . a life she could have had,” he told his interviewer.

Trullinger says she’s getting counseling and no longer feels suicidal. But her anger only deepens as she learns more, as she researches more, about why her son died.

“If the government had just told me back then that the blood supply was contaminated, I could have made a choice,” she said. “It can’t be right that they did this.”

 

__________________________________________

NYT

Title: Blood, Money and AIDS: Hemophiliacs Are Split;Liability Cases Bogged Down in Disputes

By: Barry Meier

Date: June 11, 1996

Source: The New York Times 

Last December, Corey Dubin, a hemophiliac infected with the virus that causes AIDS, met for lunch at a Carrow’s restaurant in Camarillo, Calif., with John Bacich, the president of a Baxter International Inc. unit that makes blood-clotting products.

Mr. Dubin, like an estimated 6,000 to 10,000 hemophiliacs nationwide, became infected with H.I.V. after receiving a tainted clotting substance made by Baxter and three other companies in the late 1970’s and early 1980’s. Hundreds of victims had sued. But statutes of limitations prevented thousands more from bringing claims. Mr. Dubin however had not come to lunch to pick a fight. Rather, dissatisfied with the way key plaintiffs’ lawyers were handling the litigation, he was on a stealth mission to negotiate, for all those infected, a settlement with the four companies without the knowledge of key plaintiffs’ lawyers.

I told him they were going to have to live with us as customers when all the high-powered litigators were gone,” said Mr. Dubin, a 41-year-old former journalist from Goleta, Calif., recalling the lunchtime conversation with Mr. Bacich. “If you buy a Pinto from Ford that blows up, you can tell Ford to go to hell. But I don’t have that luxury.”

In many cases of mass litigation, corporations are able to buy themselves settlements that enrich lawyers but leave the victims — faceless names on the cover sheets of legal documents — with a pittance. In the hemophilia litigation, some claimants jumped off the page to try to influence the outcome of an emotionally charged dispute.

The result of their revolt was a legal free-for-all for plaintiffs, lawyers and companies alike. United by their disease, hemophiliacs were divided between activists seeking to squeeze the maximum settlement out of the drug makers and others willing to accept less money so that the sickest among them, dying at the rate of one a day, could get some cash. Some actors included Mr. Dubin, president of the Committee of Ten Thousand, an activist group; Jonathan Wadleigh, the committee’s founder; Robert Baldwin, who gained prominence as a counselor for hemophiliacs, and David Shrager, a plaintiffs’ lawyer who guided the case until the activists challenged him.

The defendants — Baxter; Bayer A.G. of Germany; Rhone-Poulenc Rorer Inc., a unit of Rhone-Poulenc S.A. of France, and the Alpha Therapeutic Corporation, a unit of the Green Cross Corporation of Japan — were also roiled by confusion. Today they are operating in unison. But in the past they often ignored solidarity to protect their own interests, individually discussing settlements, withdrawing them or joining together in various combinations.

In the end, the Committee of Ten Thousand failed to negotiate a deal alone. But its leaders insist their initiative was not in vain. At the very least, they say, they galvanized victims to press for higher compensation. And, according to Baxter documents, they came close to a settlement that could have required Baxter to pay out more than it will under industry’s offer last month of $100,000 for each claimant, up to a maximum of $640 million. Hemophiliacs are expected to be polled soon on their interest in the deal.

But some like Mr. Baldwin contend that the activists may have scuttled earlier deals that could have gotten money quickly to those who desperately needed it. “I’ve had mothers calling me saying that they’d be happy to get $30,000 for their son so they can buy him a new car before he dies,” said Mr. Baldwin, whose brother, also a hemophiliac, died three years ago of AIDS. It is estimated that more than 2,000 H.I.V.- infected hemophiliacs have died.

Hemophiliacs, who suffer an inherited disorder in which the blood’s clotting ability is impaired and excessive bleeding results, occupy a unique chapter in the AIDS crisis. Their fatal infection was caused by the very clotting substances, known as Factor VIII and Factor IX, that they took to save their lives. And unlike many AIDS-afflicted homosexuals, most hemophiliacs kept a low profile early on, fearful of exposing their conditions.

By the early 1990’s, however, activists discovered that Government regulators and industry officials had known since the early 1980’s that clotting products posed an AIDS infection threat. The National Hemophilia Foundation, a research and lobbying group, also understated infection risks in the early 1980’s, according to a 1995 report by the Institute of Medicine of the National Academy of Sciences.

The disclosures led to the creation of activist groups like the Committee of Ten Thousand. At annual meetings of the National Hemophilia Foundation in early 1990’s, activists parked hearses outside hotels, wore death masks and threw fake blood on industry representatives. And even moderates like Mr. Baldwin began pressing producers of the clotting substances to settle claims before they reached the courtroom.

In the fall of 1993, top executives of three companies — Baxter, Rhone-Poulenc and Alpha Therapeutic — met with leaders of the hemophilia community to outline the terms of a $125 million offer, said Mr. Baldwin, who attended the meeting. But he said that Mr. Wadleigh and Mr. Dubin appeared anxious and insisted that any decision be put off. “I didn’t know what was going on,” said Mr. Baldwin, who lives in Bedford, Tex.

He got his answer the next day: With Mr. Wadleigh as lead plaintiff, Mr. Shrager, the plaintiffs’ lawyer, filed a class-action lawsuit on behalf of American hemophiliacs. Mr. Shrager, who had previously negotiated a favorable settlement on behalf of Canadian hemophiliacs, then established a panel of claimants, led by Mr. Wadleigh, to advise him and other lawyers.

In early 1995, the United States Court of Appeals for the Seventh Circuit in Chicago decertified the lawsuit, saying it might bankrupt the industry. Soon, the partnership between Mr. Wadleigh and Mr. Shrager unraveled in a struggle over the direction of the case.

Activists like Mr. Wadleigh and Mr. Dubin favored appealing the Seventh Circuit decision to the Supreme Court, arguing it would protect the interests of all affected hemophiliacs, not just those who had already sued. But Mr. Shrager wanted to shift gears and pursue the separate Federal proceeding that had consolidated hundreds of individual lawsuits that had been filed against the producers.

The clotting producers had quietly settled many claims, but individual lawsuits had failed because most states shield blood products from traditional product-liability claims. Still, damaging documents were emerging contending that the companies had collected blood from high-risk donors like homosexuals and prisoners. Soon, informal settlement negotiations intensified.

Meanwhile tensions between Mr. Wadleigh and others on the advisory committee and Mr. Shrager had been growing. “It was outrageous,” Mr. Wadleigh said. “He said he was representing the whole community and then he’d turn around and say that he represented the individual cases.” Any talk of a settlement soon took a back seat to strife within the plaintiffs’ camp.

Finally, upset by the decision of Mr. Shrager and his colleagues not to seek an appeal, Mr. Wadleigh and his allies asked a Federal judge to replace the current cast of lawyers. The closed-door drama played out last June in the chambers of Federal District Judge John F. Grady in Chicago, according to sealed court records. Mr. Wadleigh and Mr. Dubin accused the lawyer of selling out hemophiliacs as a group to advance the cause of his clients. Mr. Shrager denied the allegation and argued that it was important for the individual cases to go forward to keep up pressure on the companies to settle.

Judge Grady backed Mr. Shrager, describing the revolt by the dissidents as akin to “passengers coming up and asking to take over the controls of a DC-10,” according to court papers. But by that time, the activists, backed by two other plaintiffs’ lawyers, Thomas Mull and Charles Kozak, were pushing ahead on a separate course.

In November, they found a new rallying cry when the companies they were suing announced a settlement for Japanese hemophiliacs that dwarfed the numbers being discussed in this country: $420,000 for each victim, with $235,000 coming from industry and the rest from the Japanese government.

The next month, Mr. Dubin and his lawyers began their secret talks with the companies. And by March, they came close to reaching a deal with Baxter that might have set the framework for a more lucrative deal than the one now on the table, according to company documents.

The documents show that in late March, Baxter considered offering $50,000 to any plaintiff who alleged H.I.V. infection from using a company product. Even though Baxter held only 20 percent of the market, the number of hemophiliacs who qualified for that plan might have been significantly higher because users could easily switch from one company’s brand to another’s. If 50 percent of 6,000 affected hemophiliacs or family members applied for the plan, a separate settlement would have cost the company $150 million, not including lawyers’ fees.

That compares with Baxter’s one-fifth share of the current proposal for paying each participating hemophiliac $100,000 — up to a cost to the company of $120 million, excluding legal fees. Mary Thomas, a Baxter spokeswoman, said the company, which favored an industrywide solution, had projected that the stillborn proposal would have cost it less than its current share of the industrywide offer. But she declined to disclose the basis for that estimate.

Along with talks to settle claims by those with cases that have not been filed, talks were also apparently under way earlier this year to settle lawsuits. Bayer, the largest company involved in the litigation with 45 percent of the market, pressed plaintiffs’ lawyers involved in individual lawsuits to reach settlements quickly, according to a lawyer familiar with Bayer’s negotiating stance. Margo Barnes, a Bayer spokeswoman, denied that the company had tried to push for settlement, adding that it had rejected entreaties from plaintiffs’ lawyers.

For now, Mr. Dubin, Mr. Shrager and Mr. Baldwin have shed their differences and are taking a united stand toward the industry’s settlement proposal. But the solidarity could be threatened by potential frictions between the some 500 people who have filed individual lawsuits and the thousands who would only benefit from a mass settlement. Mr. Dubin exalts about the activists’ role in exacting favorable terms for the hemophiliac community. “This is the first time that plaintiffs have taken a case into their own hands,” he said.

Mr. Shrager, though, says it was really hard-knuckled lawyering that brought the companies around. “Corey has done a great job of applying pressure in recent months,” he said. “But giant companies don’t offer to give away $640 million out of the kindness of their hearts.”

__________________________________________

Judge OKs 640 million settlement Title: Judge OKs $640 Million Pact For HIV-Infected Hemophiliacs

By: Donna Shaw

Date: August 15, 1996

Source: The Philadelphia Inquirer 

 A federal judge yesterday gave the go-ahead to a $640 million blood-industry settlement offer that would pay $100,000 to each U.S. hemophiliac who contracted the AIDS virus from blood-clotting products.

The preliminary approval by U.S. District Judge John F. Grady here means that notice of the offer now will be advertised in newspapers and mailed to hemophiliacs and their physicians nationwide. It does not necessarily mean that the settlement will go through.

Nor does it mean that all the details have been worked out. In particular, lawyers for both sides still are seeking a way to protect the Medicaid eligibility of hemophiliacs enrolled in that program who wish to settle. Medicaid is based on financial need.

The offer resolves one crucial issue in that it guarantees each claimant $100,000. Earlier versions of the deal did not have a guarantee.

Under terms of the agreement, HIV-infected hemophiliacs or their survivors will have 60 days either to accept the offer or opt out of the deal and continue pressing their court cases. Infected spouses and children also are eligible for payments.

“We believe the settlement is fair, reasonable and in the best interest” of those eligible, industry attorney Phil Beck told Judge Grady yesterday during a 75-minute hearing.

The companies and attorneys for the hemophiliacs agreed on the settlement after what both sides described as “hard-fought” negotiations.

David Shrager, the Philadelphia lawyer who is lead counsel for the consolidated federal cases brought by HIV-infected hemophiliacs, said that one reason for the settlement was the difficulty individual victims might have in seeking harsher verdicts from the companies.

“The fact of the matter is this a very dicey item of litigation and for many people there is no [other option],” he told the judge.

The pharmaceutical companies taking part in the offer are Rhone-Poulenc Rorer Inc. of Collegeville, Pa.; Bayer AG of Germany; Baxter Healthcare Corp. of Deerfield, Ill.; and Alpha Therapeutic Corp., a U.S. subsidiary of Japan’s Green Cross Corp.

Hemophilia activists estimate that as many as 10,000 hemophiliacs contracted the disease in the late 1970s and early 1980s, before blood-clotting medicines were heat-treated to kill viruses. The clotting drugs – necessary because hemophiliacs sometimes bleed uncontrollably – were made from the pooled plasma of thousands of donors, most of them paid.

The four clotting-drug manufacturers estimate that 5,000 to 8,000 people will apply for the settlement. Of the $640 million total, $600 million is for the hemophiliacs and $40 million is set aside to pay their attorneys.

The companies are reserving the right to withdraw their offer if a significantly higher than estimated number of people apply for the settlement or opt out of the agreement to try to pursue their cases on their own – though both sides agreed yesterday that was unlikely.

Attorneys for the hemophiliacs estimate that there will be at least 500 opt-outs. That includes 100 or more from New Jersey, where a recently enacted law extended the state’s two-year statute of limitations to allow HIV-infected hemophiliacs more time to file suits against the industry. The companies have filed a court challenge to the law, arguing that it is unconstitutional.

Lawyers and hemophilia activists predict that the industry’s settlement plan will be accepted by most of those affected, whose treatment costs for HIV and their bleeding disorder can exceed $100,000 per year. They say most of the hemophiliacs need the money, are tired of fighting, or are barred from suing because of statutes of limitations in their home states.

Yesterday’s action was only the beginning of the settlement process, and it will be many months before any money is paid out. Judge Grady advised the lawyers to make sure that those applying for the settlement know it will take time. “Just don’t imply that this thing is around the corner,” he said.

The lawyers are considering establishing a toll-free telephone number for those who might be eligible to call with questions.

The lawyers also must find a way to prevent the states from taking part or all of the settlement money from recipients of Medicaid and some other publicly funded programs. The federal government, which funds Medicaid, requires states to seek such reimbursement. Estimates of how many hemophiliacs are enrolled in the Medicaid program vary widely, but it is believed to be a substantial number.

Shrager, the attorney for the hemophiliacs, has said the settlement won’t be acceptable unless recipients are permitted to keep their Medicaid eligibility and the money.

Guy Esnouf, a spokesman for Rhone-Poulenc Rorer, said the companies are working with Washington lobbyists to find a solution.

The settlement is separate from any compensation that might be offered by the federal government for its role in the epidemic. A bill known as the Ricky Ray Hemophilia Relief Fund Act would set up a $1 billion compensation fund, or $125,000 per person, for HIV-infected hemophiliacs.

More than half the members of Congress are signed on as co-sponsors, but the bill has yet to be released from committee. Hemophilia activists say they have been told by congressional staffers to expect no action on the legislation until at least next year.

Last year, the federally funded Institute of Medicine concluded in a report that “a failure of leadership” by government officials was largely to blame for the HIV infection of hemophiliacs. The report recommended that Congress consider establishing a no-fault compensation system “for individuals who suffer adverse consequences from the use of blood and blood products.”

A report issued Aug. 2 by the House Committee on Government Reform and Oversight echoed that recommendation. In an interview, Rep. Christopher Shays (R., Conn.), chairman of the subcommittee that wrote the report, said the government could have responded sooner to prevent the AIDS tragedy.

 

__________________________________________

Gingrich backs billTitle: Gingrich Backs Bill To Pay $900 Million To HIV-Infected Hemophiliacs

By: Donna Shaw

Date: March 21, 1997

Source: The Philadelphia Inquirer 

 Invoking the memory of a King of Prussia man, House Speaker Newt Gingrich yesterday vowed to vigorously support passage of a bill that would pay $900 million to HIV-infected hemophiliacs.

“The federal government did not do the right thing,” Gingrich told a news conference on the Capitol lawn, referring to a federal report that criticized regulation of the blood industry. “This bill is a matter of simple justice.”

The Ricky Ray Hemophilia Relief Fund Act would pay $125,000 to each of the estimated 10,000 hemophiliacs who, in the late 1970s and early 1980s, contracted the AIDS virus from commercial blood-clotting medicines. An earlier version of the bill, named for a Florida hemophiliac who died in 1992 at age 15, never made it out of committee last year.

The new bill, which Gingrich vowed to push to the floor for a vote by the full House, contains significant changes. Among them: a new section that would prevent the government from treating the proceeds of a pending class-action settlement as income when determining hemophiliacs’ eligibility for Medicaid and other benefits. The hemophiliacs are suing four manufacturers of clotting drugs, made from the pooled plasma of thousands of donors.

Another change: The legislation has been recast as “compassionate” rather than “compensatory,” to satisfy lawmakers who did not want the government blamed. The U.S. Food and Drug Administration was the agency responsible for ensuring the medicines were safe.

The compromise comes as lawyers for hemophiliacs are finding new evidence that the FDA did not stop manufacturers from using the plasma of high-risk donors in hemophilia products – even after the U.S. Centers for Disease Control published a July 1982 report linking tainted blood-clotting drugs to AIDS in hemophiliacs.

In an August 1982 memo discovered recently by the lawyers, an FDA official describes a meeting with regulators and industry officials at which they discussed four units of plasma that were collected from an AIDS patient for his hepatitis antibodies. The units were pulled from production because they had thawed during shipping, the memo states.

The memo says that under “usual circumstances,” the plasma would have been pooled with other units collected for immune globulin. From there, the portion of plasma used to make hemophilia medicines “would have been removed and pooled” with material “from ordinary plasma pools” used to make clotting medicines.

Donors at high risk for hepatitis and other diseases were recruited by industry because their plasma was a rich source of antibodies used in immune globulin and diagnostic products, as well as for research.

An FDA spokesman said the agency would not comment on the memo while the matter is in litigation.

At yesterday’s news conference, Gingrich said he decided to push the new Ricky Ray bill after receiving a visit from the brother of a King of Prussia hemophiliac, Michael Burke, who died last month.

Burke’s brother, Ed, visited Gingrich two days after Michael Burke died and pleaded for help, Gingrich said. He said he agreed to push the bill “in honor of Ed’s brother and all the others who have died.”

Among the Ricky Ray bill’s cosponsors so far is Jon Fox (R., Pa.), the Montgomery County congressman who represents the Burke family. Michael Burke was married with two children.

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