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How safe is our blood supply?

For 1/2 years the Centers for Disease Control (CDC) in Atlanta gathered the unsettling evidence. First, two Colorado men who had received blood from the same donor tested positive for the AIDS virus. Then, following a car accident, a 66-yearold woman contracted AIDS from a transfusion and died a year later. Next a 55-year-old man developed classic symptoms of AIDS 20 months after receiving plasma during coronary bypass surgery. In all, the CDC found 13 of these cases that occurred after mandatory testing of the nation's blood supply for human immunodeficiency virus (HIV) began in 1985.

Every year about 3 .5 million Americans receive one or more units of blood in a transfusion. What are the chances of getting AIDS or hepatitis-the two biggest concerns-ftom it? And how can you minimize your risk?

Ross D. Eckert, an economics professor at Claremont McKenna College in Claremont, Calif., has written widely on the blood-banking industry. He says, "Before AIDS blood testing began, government officials and blood bankers suggested the public's concern about the blood supply was unwarranted hysteria. In my view it was completely rational-and still is."

According to CDC estimates, more than 10,000 Americans are infected with the AIDS virus, because of transfusions, and an additional 10,000 people with hemophilia are also HIV positive. Many don't even know they. have the disease, and can infect others. As yet, there has been no systematic national effort to trace all these people.

This makes James Shannon, a 52-year-old Washington, D.C., businessman, very angry. (Names of victims in this special report have been changed to protect privacy.) In late 1982 Shannon underwent coronary bypass surgery that required 20 units of red blood cells. (A unit is the amount taken ftom a pint of blood.) Shannon recovered quickly, but later felt too ill to function well. "The idea that I could have AIDS never crossed my mind," he says.

Then in May 1987 Shannon read an article on AIDS that said people who had received transfusions between 1978 and 1985 were at risk. He was tested, and his worst fears were confirmed. "What angers me," Shannon says, "is that neither the hospital where I was operated on nor the Red Cross that supplied the blood ever contacted me about AIDS. If I had been sexually promiscuous, there's no telling how many people I could have infected."

He says he'd be much angrier if his wife had gotten AIDS. Thus far, all her tests have been negative.

What also angers a number of experts is that the blood industry and the federal government failed to do all they could to safeguard the supply when AIDS began spreading in the early 1980s. Many blood bankers and federal officials deny this. But industry critics contend there were ways to reduce the risk of transfusion AIDS nearly two years before the present test went into effect. They say blood bankers, to protect their own interests, ignored these methods.

Guilt by Association

Blood banking, a "nonprofit" industry, is big business. It collects almost 13 million pints of blood a year from volunteer donors and sells nearly 30 million units of blood products. The American Red Cross, the biggest player, collects about half the donated blood. Independent banks collect some 40 percent, and hospitals take in the rest. (Apart from the nonprofit blood industry, there are commercial plasma centers that collect mostly plasma from paid donors; this is then manufactured into a variety of blood products.)

Annual sales of nonprofit blood amount to $1 billion. In 1986 Money magazine concluded that if Red Cross Blood Services were a for-profit corporation, its fiscal 1985 revenues would place it number 473 among the Fortune 500, and its hypothetical 8.8-percent earnings would tie for 50th place.

"Blood banks are portrayed as heroic, altruistic organizations," says economist Eckert, "But in fact in most communities they have been either monopolies or cartels. Tighter screening forces them to discard more product, which means lost revenues, and to solicit even more donors. That's why they were slow to respond to the AIDS threat."

Eckert is not the only one who feels blood banks took too much time to respond. Dr. Edgar Engleman, medical director of the Stanford University Blood Bank in Palo Alto, Calif., concluded by early 1983 that it was "patently obvious" AIDS was transmitted by blood andprobably constituted a much bigger problem than generally acknowledged.

Engleman's concern led him to adopt a blood screening test for AIDS. His was the first known blood bank in the nation to do so. While his test would not find AIDS directly, it identified abnormal white-cell ratios associated with AIDS patients and people in high-risk groups, such as homosexuals and intravenous drug abusers. Such "surrogate tests" determine guilt by association.

The Stanford blood bank started screening in July 1983, nearly two years before mandatory AIDS testing. To pay for the test, the bank added $6 to the cost of each transfusion. "No patients complained," Engleman says.

Donor's Confession

The following spring, a frantic call came to Stanford from a doctor 500 miles away. "An AIDS patient had just told him that he had donated blood at Stanford and other banks in our area," Engleman recalls. "Our records showed his blood had tested abnormal and was thrown out. Unfortunately, the other banks gave his blood to as many as 11 recipients."

With the advent of the present AIDS test (called ELISA, for enzyme-linked immunosorbent assay) in March 1985, Engleman went back to see how well his surrogate test had worked. Seven and a half percent of the "high-risk" blood he had discarded was infected. But for each 1000 specimens from blood that had tested safe and been transfused, one tested positive for the AIDS virus. So Engleman's test, while not perfect, had undoubtedly reduced transfusion AIDS at Stanford.

If his test had any chance of succeeding, why didn't other blood bankers rush to use it? "I don't contend the blood bankers should have used our test," says Engleman. "But they could easily have started testing by 1984 using the hepatitis B core antibody test as a surrogate AIDS test. This would have been a good test to help prevent transfusion AIDS, and they were well set up to do it."

This second procedure detects antibodies at the core of the hepatitis B virus. According to a 1983 CDC study of AIDS patients, these antibodies were present in all intravenous drug users and in 88 percent of male homosexuals. By identifying this high-risk blood, the surrogate test could have prevented some cases of transfusion AIDS.

Blood banks in San Francisco, along with a few other areas, where fear of transfusion AIDS ran highest, instituted just such a test in the spring of 1984. (Some commercial plasma centers had also been using the test.) But all the other blood banks refused. They continued to assure the public that all that should be done was being done.

Dr. James P. AuBuchon, medical officer at the American Red Cross national headquarters in Washington, D.C., replies that the surrogate testing Engleman used was impractical. "It's an expensive test," he says. "There were not enough instruments in the country to perform it. It would have been logistically impossible to do 13 million tests a year. And the hepatitis B core antibody test is not reliable for AIDS. "

However, clear evidence that the hepatitis test would have curbed AIDS comes from Dr. Herbert Perkins, director of the Irwin Memorial Blood Bank in San Francisco. Irwin began using the hepatitis antibody test in May 1984-nearly a year before the ELISA test was available. "Looking back, we now know that 40 percent of donors who test positive for AIDS also test positive for the hepatitis B antibody. So our testing did prevent a certain percentage of AIDS cases."

Closing the "Window"

Given the past foot-dragging, how well is the blood supply protected now?

The first line of defense is that donors are asked not to give blood if they have been exposed to infectious diseases, such as malaria, hepatitis or AIDS, or if they are in a high-risk group for AIDS.

Unfortunately, the 13 recent transfusion AIDS cases prove that some donors slipped through this defense. To find out why, the CDC located and interviewed six of them. "Most were homosexual or bisexual men," reports Dr. Scott Holmberg, a medical epidemiologist with the AIDS program at CDC. "One was a woman who had sexual contact with a former I.V. drug abuser. In one disturbing case, a gay man admitted donating blood to get a free AIDS test."

The blood of these people also eluded the second line of defenselaboratory testing. The ELISA test does not reveal the AIDS virus itself, but the antibodies that form in response to it. The problem is that the immune system usually takes three months to produce detectable numbers of these antibodies. The blood of an infected person can slip through thi"window."

How much is slipping through? No one knows. But the CDC estimates that a patient's chance of getting infected with the AIDS virus ftom a unit of transfused blood is about one in 100,000. By contrast, the average person's chance of getting killed in an auto accident in a year is about one in 5000. However, the CDC points out, it isn't presently known whether all or just some of the people infected with the virus will eventually develop AIDS.

Researchers are looking for better ways to screen blood. "Experimental tests are picking up the AIDS virus only a week after infection," says Dr. Frank Young, commissioner of the Food and Drug Administration (FDA), the federal agency that regulates the nation's blood supply. "But a version for routine use is probably two years away."

Until then, the final word on the risk of transfusion AIDS comes from the authors of the CDC study. They call the ris"remote but real."

Big Chill

Even if a foolproof AIDS test for HIV is developed, it's likely that new risks-new viruses-will emerge to imperil the blood supply. Last December, doctors at the University of Medicine and Dentistry in Newark, N.J., examined a woman who had been losing weight for three years and suffered unexplained neurological symptoms. A CAT scan found brain lesions typical of AIDS-but she tested negative for the disease.

The woman had recently migrated to the United States from West Africa, where a virus called HIV-2 is prevalent. She became the first HIV-2 victim in the United States, and her case symbolizes a new menace to the nation's blood supply.

HIV-2 and another virus called HTLV-1 (human T-cell lymphotropic virus), along with AIDS, are in the same family of retroviruses. (A retrovirus is a type of virus that processes its genetic information differently ftom other viruses.) HIV-2 causes an AIDS-like disease. HTLV-1 causes a devastating form of adult T-cell lymphoma/leukemia, and a nerve disorder called tropical spastic paraparesis, which resembles multiple sclerosis. Both viruses are believed to be transmitted the same way as AIDS-by sexual contact, needle sharing and blood, and from mother to unborn child.

Heavy pockets of HTLV-I have long existed in southern Japan and the Caribbean, and to a lesser extent in central Africa. More recently, the virus has been detected among I.V. drug abusers in Britain and in many large U.S. cities. HIV-2 has been found in West Africa and two European countries.

Early last year, the Red Cross, using experimental tests, randomly checked 39,898 units of donor blood for antibodies to HTLV-I. The tests turned up ten units of HTLV-I positive blood, or 2 1/2 units per 10,000. This makes the risk of getting HTLV-I through a transfusion higher than the risk of getting AIDS. A survey of 8503 blood samples by the CDC and FDA found no HIV-2.

"Approving a test for HTLV-I is one of our highest priorities now," says FDA Commissioner Young. "We hope to approve one any moment. And the HIV-2 test will be right behind it."

Meanwhile, a researcher in Italy may have found yet another retrovirus he calls HTLV-V, which causes another type of lymphoma. Are even more viruses coming? "We don't know," says CDC's Holmberg. "It's possible that AIDS may be just one piece in a larger puzzle. That's a chilling thought, but I think we need to be chilled."

Hepatitis Risk

Just one week after his discharge from cardiac surgery, Paul Griffith, in his early 60s, began feeling weak. "I'd walk ten minutes and sleep four hours," he says. Tests revealed he was suffering from hepatitis, a serious infectious disease of the liver.

Because pre-admission tests showed he didn't have hepatitis, Griffith knew he'd contracted it ftom transfusions. His type of hepatitis is called Non-A, Non-B (NANB).

Griffith's fatigue persisted. Soon he was forced to retire from his law practice. Two years later, a biopsy revealed that Griffith, a teetotaler, had cirrhosis, a harmful inflammation of the liver caused by the hepatitis. For the past six years, because there is no effective treatment for NANB hepatitis, Griffith has suffered recurrent fevers, chills, hemorrhaging and abdominal pains. He is dogged by fatigue and poor appetite. He has lost 70 pounds. "I can't fault anyone," he says. "No one intentionally tried to harm me."

Not until the AIDS crisis focused attendon on the blood supply did the risk of hepatitis come to full public view. Before blood banks started new NANB hepatitis screening tests in 1986, the chances of getting this disease ftom a transfusion were about one in ten. That made hepatitis by far the greatest transfusion risk, with 300,000 to 400,000 transmissions each year. Now, with new tests, some experts feel the risk has been cut to one in 20.

Ninety percent of transfusion hepatitis is NANB. Most of the rest is hepatitis B, a form that can persist and, in some cases, kill. A third kind, hepatitis A, poses little transfusion risk because it is an acute illness with no chronic carriers.

In the 1970s, blood banks took steps to protect against hepatitis B, which was then thought to be the most prevalent form. They began using a test that detects the virus. They also stopped paying donors. Studies proved that paid donors-many from skid row-had a significantly higher incidence of hepatitis B than did other volunteers.

NANB hepatitis, however, continues to threaten transfusion recipients because there is no test to detect the virus or its antibodies. Most people with NANB hepatitis don't realize they have it. Many of them unknowingly donate blood.

In late 1986 blood banks finally began using two surrogate tests for NANB. One is the hepatitis B core antibody test-the same test Engleman advocated as a surrogate screening for AIDS. Studies find that people who test positive for hepatitis B antibodies are also at risk of NANB. The second test is called alanine aminotransferase, which measures liver enzymes whose blood levels are raised by many things, including alcohol consumption and NANB hepatitis.

Experiments suggest that virtually everyone given NANB-tainted blood becomes infected. Sooner or later, half of those infected get chronic hepatitis, and ten percent go on to develop liver cirrhosis. Even with the NANB surrogate tests, a patient's chance of developing cirrhosis from blood transfusions is one in 200.

Though testing has made the blood supply considerably safer, the risk of transfusion hepatitis remains high. But a California company has announced it has identified the NANB virus. "Preliminary results are very encouraging," says Dr. Harvey J. Alter, chief of immunology at the National Institutes of Health (NIH) department of transfusion medicine. "If the discovery is confirmed, it will represent a major advance in the prevention of NANB hepatitis. A specific NANB test within two years is now an attainable goal."

Beating the Odds

"There's always going to be a new virus or a permutation of an existing virus, and we're always playing catchup," says Dr. Harvey Klein, chief of transfusion medicine at NIH"Ideally, we'd like to have something to eliminate all viruses from the blood. "

Klein's idea is not science fiction. Two methods of deactivating viruses -called "blood cleansing"-are now under study. One uses laser beams, the other chemicals. "For massive blood screening, both of these techniques are still a way off," says the FDA's Young. But other possibilities remain:

"Artificial blood." This term is misleading, because the real focus of research is the development of chemically modified hemoglobin, the oxygen-carrying protein in blood. In animal experiments, this chemical solution delivers oxygen as well as and possibly better than natural blood. Gene-splicing techniques may be used to mass-produce it. We could see limited use of this "artificial blood" in patients as soon as a year from now. The substance would most benefit patients who lose massive amounts of blood in surgery or trauma.

Blood salvage. This method collects blood a patient loses during surgery and pumps it into a machine that separates out the red cells, washes them and reinfuses them into the patient. Blood salvage can sometimes eliminate or minimize the need for transfusions-but it requires a $35,000 machine and a technician to run it. (A few major hospitals around the country now offer this service.)

Self-donation. Storing your own blood is the surest way to eliminate risk. Because you can donate up to a pint of blood a week under optimal conditions, and red cells keep for up to six weeks, you can store about five units before some surgeries. Consult your physician first, however.

Commercial firms now offer bloodfreezing for up to ten years. The annual cost is about $150 per unit. But frozen blood requires time to thaw, and would not be available in some emergencies.

"Creating your own blood bank not only protects you against infections, but also protects you against certain adverse reactions that occur in five percent of donor transfusions," says Dr. Joseph Feldschuh, president of Idant Laboratories in New York City.

While self-donation laboratories are regulated by the FDA, quality control is not uniform. Ask for recommendations ftom your area blood bank and your physician.

Designated donation. This involves simply asking friends and relatives to donate. Most blood banks allow this, but discourage it because there is no evidence that such blood is safer. "If you know the donors very well and are sure they are not in a high-risk group, designed donation may protect you against transfusion AIDS," says the FDA's Young. "But against NANB hepatitis, I don't think it's any help at all."

One sure way to reduce transfusion risk is to cut the number done. "I can't prove it," Young says, "but I think many transfusions are unnecessary. We have to educate our physicians better in this regard, and develop clearer guidelines."

Until that happens, given the tests available, the blood supply is as safe as can reasonably be expected. Says Dr. Thomas S. Asher, chairman of HemaCare, a commercial blood-technology firm in Sherman Oaks, Calif.: "Over the years, the nonprofit blood industry grew big and arrogant and began to lose sight of its goal of service. But in the past year or so the blood bankers have truly seen the light and are more responsive. It's called consumerism, and the public will be better served because of it."

This new commitment, coupled with technology, may someday make the blood supply completely safe. For the present, though, it may be well to heed the words of the experts: blood is a risky form of medical therapybut it can also save your life.
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Copyright 1988 Gale, Cengage Learning. All rights reserved.

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Author:Pekkanen, John
Publication:Saturday Evening Post
Date:Sep 1, 1988
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