$30-Million U.S. Blood Bank Hunt for Rare AIDS Virus Comes Up Empty : Medicine: Some believe the HIV-2 testing was driven as much by fear of violating a fearful public’s demand for safety as it was by any real medical need.

In the summer of 1992, the U.S. Food and Drug Administration took a resoundingly non-controversial step in the war on AIDS: It ordered all blood banks to test for a virus called HIV-2.

Even though the virus was rare to the vanishing point, no one seriously opposed the directive, not even the blood banks, which would have to pay for the testing. In fact, they publicly welcomed it. The subject of expense hardly came up.

This was another virus that causes AIDS, after all, the most dreaded of all diseases. The blood banks inadvertently helped spread the AIDS epidemic in the early 1980s. Neither they nor their regulators wanted to make that mistake again.

“Cost was not a factor,” recalled Dr. Charles Wallas, president of the American Assn. of Blood Banks.

So over the last year and a half, the blood banks have spent an estimated $30 million testing all donated blood for signs of HIV-2.

The result: Not a single infected donation has been found.

That’s right. The country’s blood banks have tested about 20 million units, and they have not turned up one drop of bad blood.

Unlike HIV-1, the primary AIDS virus that probably infects somewhat under 1 million Americans, HIV-2 is almost impossible to find in the United States. No one knows precisely how many people have it, but intensive searching has turned up less than 50 cases nationwide.

Some of those involved say HIV-2 testing was driven as much by fear of violating an apparently uncompromising public desire for blood safety as it was by any real medical need. Blood bankers themselves are of two minds about it.

“Why are we doing HIV-2 testing? We are erring on the side of caution,” said Dr. James MacPherson, head of the Council of Community Blood Centers. His organization represents the nonprofit, non-Red Cross blood banks that collect about 35% of the nation’s blood.

But Dr. Paul Holland, medical director of the Sacramento Medical Foundation Blood Center in California, said the testing represents a hopeless attempt to make the blood supply 100% safe, no matter how slight the risk or how high the cost.

“In my opinion, it was not a good decision, then or now,” Holland said. “We had zero evidence that HIV-2 was being transmitted by blood donors in this country.”

Federal officials and blood bankers agree they feel pressure to remove all risk from transfusions, a quest for perfection that exists almost nowhere else in medicine.

Regardless of whether HIV-2 testing was the right thing to do, many in the blood banking world believe it was unavoidable. The sad history of AIDS made it so.

In the late 1970s and early 1980s, AIDS spread silently through the nation’s blood supply. No one knew what caused the disease, so there was no clear way to stop it. About 6,400 Americans, including tennis player Arthur Ashe, got AIDS from transfusions or other blood products.

Eventually, researchers learned the culprit was the human immunodeficiency virus--HIV-1. In 1985, a test became available to screen for it, and the blood banks immediately began checking all donations. But there was criticism that the blood banks and FDA should have done something sooner.

Some suggested they should have looked for so-called surrogate markers. Testing blood for elevated liver enzymes, for instance, might have provided a clue to hepatitis infection, which was known to be more common in people infected with AIDS.

No one knows if surrogate testing could have improved blood safety. But some said the blood banks held back to save money.

“We are very sensitive to those charges,” said Wallas. “Given that people tend to learn from past experience, we made a decision that cost should not be part of our decision making.”

HIV-2 gave all involved a chance to show they had indeed learned a lesson from AIDS.

The virus is a cousin of HIV-1 that is confined largely to West Africa. Even though HIV-2 is harder to catch than HIV-1 and causes disease more slowly, the ultimate effect is the same--AIDS.

In 1992, a combination test came on the market to screen blood for HIV-1 and HIV-2 at the same time. By then, health officials knew of just 18 cases of HIV-2 infection in the United States, nearly all in African immigrants. The question arose: Should blood banks be required to use it?

Already there had been a brush with HIV-2. In 1986, a U.S.-born woman who had traveled in West Africa donated blood infected with HIV-2. But her tainted donation never made it into the blood supply, because it was spotted by the HIV-1 test. Because HIV-1 and HIV-2 are so similar, the standard HIV-1 alone test can find HIV-2 between 60% and 90% of the time.

To learn how common it was, health officials screened 20 million blood donations for HIV-2. They found no cases. Even when they focused their search where they would most expect to find it--in venereal disease and drug abuse clinics in cities with large numbers of West African immigrants--they located just two cases among 31,533 people tested.

The U.S. Centers for Disease Control and Prevention estimated that if routine testing began, at worst, 2.6 of every 10 million pints of donated blood would harbor the virus, but the true figure could well be zero. Since the standard HIV-1 test will find at least two-thirds of HIV-2 infections, checking specifically for HIV-2 would, at most, eliminate one bad unit of blood yearly.

With all this information, the FDA ordered blood banks to use the new combination test beginning in June, 1992.

“We thought it was the right thing to do, and we thought the public expected us to do it. The alternative was the risk of a recipient getting infected with this virus,” said Dr. Peter Tomasulo, chief operating officer of the American Red Cross, which collects 45% of the nation’s blood.

Although HIV-2 was hardly a public health threat, no one could guarantee it would never spread. And certainly no one wanted to explain how they allowed even one person to catch the virus when a test could have prevented it.

“The bottom line was that if we wanted assurance of preventing HIV-2 transmission, HIV-1 screening was not adequate,” said Dr. Jay Epstein, head of the FDA’s Office of Blood Research and Review. “Given the concern about HIV, which was special because of the horror of what happened in the early ‘80s, there was a climate that not doing whatever could be done was seen as unacceptable.”

MacPherson estimates that HIV-2 testing costs $20 million annually. It adds about $1.50 to the price of a $100 pint of blood.

The combination test itself costs about $1 more than the standard HIV-1 test. Other expenses include keeping track of those who test falsely positive, so they will not donate again, counseling these donors about what their positive test results mean and finding new donors to replace them.

Money is not the only cost. MacPherson estimates that adding HIV-2 to the AIDS test has doubled the number of falsely positive results to 5,000 annually.

Even though their blood is safe, the donations are thrown away, and these donors are told not to give blood for six months. If their blood turns up positive again, they are asked to refrain from donating again.

“It is the worst nightmare to get a call from a blood center saying we have found something in your blood,” said Dr. Thomas Zuck of the University of Cincinnati. “We try to explain that they reacted on a test to antibody for AIDS. You can imagine how upset these people are, and they won’t believe they are not infected.”

Whether all of this is protecting the nation from an outbreak of HIV-2 is unclear. The CDC said that, at last count, it had found 48 people with the virus. There was no sign HIV-2 had begun to spread.

“Did we jump the gun, or were we very smart in implementing something before it’s needed?” asked MacPherson. “We need a few more years to know.”