Item. Many FDA inspectors are ill-trained to detect problems in computerized, high-tech facilities. Some inspectors still have not been trained to interpret results of AIDS tests, four years after blood banks started using them.

Item. The FDA has relied heavily on the blood industry in setting safety standards. In 1984, the agency rejected use of a test that some experts said could have identified nearly 90 percent of the blood donors at high risk for AIDS. The agency based its decision on recommendations from two industry-dominated advisory groups.

The plasma facilities collect and process blood plasma into a number of finished products, such as Factor VIII blood-clotting concentrate and hepatitis vaccines. In addition, nonprofit blood banks collect whole blood and separate it into its various components - red blood cells, platelets and plasma.

The records also show that testing errors were occurring in blood banks and plasma centers even before testing for AIDS began in 1985. Those errors involved the release of products that repeatedly tested positive for hepatitis.

"By 1983, everything epidemiologically was pointing to a contagious agent that was probably blood-borne," said Dr. Bruce Evatt of the federal Centers for Disease Control and an expert on blood diseases.

Yet it would be five more years before the FDA required any testing of blood for the AIDS virus. By then, 60 percent of America's 20,000 hemophiliacs - 12,000 people - had been infected through contaminated blood-clotting medicine.

"Would we like to have more people who are trained in laboratory medicine who could do inspections? Absolutely. We're moving more and more to specialists."

FDA officials are currently preparing what they call a "unified memo" on AIDS that will consolidate all the agency's previous recommendations. Among them is a new recommendation that blood banks and plasma centers notify donors who test positive for AIDS.

The notification recommendation comes more than four years after the blood industry began to test donors for the disease.

"That's true. We are adding it in the informed consent. You should be told when you give blood now and test positive," said Joel Solomon, who became director of the FDA's Division of Blood and Blood Products in 1988.

"I don't know why it wasn't done before. I wasn't here then. What happened before I can't speak to," Solomon said.

But the recommendation is just that. It will not carry the force of law, as a regulation does. If a blood bank or plasma center chooses to ignore it, it can do so with immunity.

In May 1986, an FDA agent spent three days inspecting the Community Blood and Plasma Center on Race Street. According to a report the inspector later prepared, he found several deficiencies, none of which appeared to be life-threatening.

They were serious enough, however, that a report was written and given to officials at the center pointing out what needed to be corrected.

An inspector did not return to the facility until two years later, on April 5, 1988. That was when FDA investigator Richard E. Harrison found that donors with positive test results for AIDS were not being notified, as required by the center's own standard operating procedures.

"The SOP calls for letter notification to all donors found reactive," Harrison's report notes. "I found that this facility has not sent notification letters to such HIV (Human Immuno-deficiency Virus, the AIDS virus) positive donors . . . since as far back as 5/21/87."

Documents describing the inspection do not indicate how many plasma donors tested positive for AIDS in the period examined by Harrison. A company official said it was "only a few." However, during the three days Harrison spent at the center, he reported seeing at least two such blood donations being destroyed by workers.

During a discussion with the FDA agent following his inspection, center officials conceded they "should have been sending out the letters as required," according to Harrison's report.

"I pointed out . . . that waiting for all donors to come in and then notifying them was not the best way to do it as, given the inconsistent attendance of donors and the high dropout rate, some positive HIV test donors might not come in again for a long while or even ever again and would thus remain uninformed," Harrison's report says.

The Race Street center is one of 16 that collect plasma from paid donors for Immuno-US Inc., a subsidiary of Immuno AG, a large, for-profit plasma manufacturer in Vienna.

On April 25, 1988, FDA officials asked a representative of Immuno-US what the company was doing to correct the problem at its Race Street operation.

On May 6, the company's president, Eugene A. Timm, responded: "Letters are now being mailed after verification of lab results."

In explaining why the center stopped mailing notices, Timm wrote, "This is because our local center management bowed to the request from the local Health Office not to send out such letters."

Richard Dice, executive director of Community Blood and Plasma Inc., said in an interview earlier this year that the Race Street center was contacted by an official from the Philadelphia Health Department "in mid-1985. My recall is the Health Department called us and frankly told us not to report positive test results to the donors. I thought it was some doctor with the Health Department. I can't recall his name."

Former and current administrators at the city Health Department could not recall contacting the plasma center in 1985. However, Dr. van de Beek, director of the city's AIDS Activities Coordinating Office, said a representative of his office did contact the plasma center in 1987.

CONTACTING DONORS

Dr. van de Beek said at least one donor who had received a letter from the plasma center and "was considering suicide" turned out, after additional testing, not to have AIDS.

"It became apparent to us there was an incredible threat to the health of individuals receiving information in this fashion," he said.

"We basically told them (plasma center officials) that there was a much more compassionate way to do this. What these people really need at a time like this is a hug. They need medical care. This is not something you learn about by mail," van de Beek said.

He also insisted his group did not tell the plasma collection center to stop notifying donors by letter - only that it be done after proper testing and that those who tested positive for AIDS should be brought in for counseling.

"That (the decision to stop sending letters) is the first I've heard of that," van de Beek said. "(With proper notification) those individuals who are infected could get life-saving therapies and get information that could save the lives of other people."

FDA officials, meanwhile, accepted Timm's April 1988 explanation that letters were again being sent to donors testing positive for AIDS and filed it away.

"We have placed this material in this facility's file and its contents will be verified at the time of the next inspection," a compliance officer informed Timm in a letter dated May 17, 1988.

And while a subsequent inspection found that letters were indeed being mailed, the inspection did not take place until November 1988 - six months later.

The FDA has never told blood banks and plasma centers that they must inform donors who test positive for AIDS. In October 1985, the U. S. Public Health Service recommended notifying donors and referring them to doctors for an evaluation. But these recommendations were never made into law.

*

The FDA has been slow to formulate requirements covering the use of computers by blood banks - in part, due to its own lack of expertise - or to develop proficiency standards covering tests used for AIDS and hepatitis.

While blood banks have used computers for years, it was not until this month that specific FDA requirements governing computers were issued. They mandate that blood banks must be able to show that their systems perform consistently and accurately. And while the agency has drawn up a proposed rule requiring blood banks to have independent outside auditors review the accuracy of their testing, a top FDA official conceded she "didn't know what we will do if someone fails the program."

The FDA recently provided an answer. Officials announced in June that they "would work closely" with any blood center that fails the testing program "to improve the quality of its performance."

In March, the FDA published a notice in the Federal Register indicating that its inspectors would not even ask to see "reports of any internal audits conducted by an (outside) firm to determine compliance with its own quality assurance program when the quality assurance program is required by regulation."

"FDA will not review or copy reports and records that result from audits and inspections of a written quality assurance program," the agency said in a June notice in the Federal Register clarifying its position.

In other words, an independent audit might find potentially dangerous problems in a blood bank. But unless the FDA knew about the problems beforehand, agency officials would not ask to see the audit records.

That approach reflects the extraordinary trust the agency places in the industry's willingness to regulate itself.

Indeed, the FDA often relies on the industry for advice.

The close relationship between the agency and the industry is reflected in many of the actions taken by the FDA's Blood Products Advisory Committee.

Formed in 1980, the committee's charter calls for it to advise the "commissioner in discharging his responsibilities as they relate to assuring safe and effective biological products and related medical devices."

Until recently, committee members were almost exclusively blood-bank officials and medical researchers. As of May, 10 of the committee's 11 voting members came from the blood industry or were physicians and/or researchers. The chairwoman, Dr. Louise J. Keating, is the director of the Red Cross blood bank in Cleveland.

The committee includes a consumer representative and an official from the commercial plasma industry, but neither is allowed to vote.

"Even today, it remains what I call an Old Boys' Club," complained Thomas Asher, chairman of a California company that sells specialized blood products. "It's insular to a fault and it's very protective of its own self-interests."

In its June 1988 final report, the Presidential Commission on AIDS warned against this close government-industry relationship, saying it fostered "a relationship that presents a significant opportunity for conflicts of interest."

In April 1988, Eckert, the Claremont McKenna College economist, was appointed to the committee. "Clearly, there hasn't been enough diversity," he said in an interview. "My appointment is a step in the right direction, but there needs to be a lot more done."

While the committee's charter directs it to offer advice, in practice it does much more. It helps shape policies affecting the collection, distribution and testing of blood. Moreover, a review of more than a dozen hearings since 1982 shows that its recommendations are rarely rejected by FDA officials.

For instance, the FDA turned to the committee in 1983, when it was trying to decide whether blood banks should be required to use a test for identifying high-risk donors for AIDS.

Studies at the Centers for Disease Control, made public at a widely attended meeting in Atlanta in January 1983, had showed that nearly 90 percent of AIDS patients and others considered at risk of developing AIDS had antibodies in their blood indicating a history of hepatitis. Thus, CDC officials reasoned, in the absence of a specific test for AIDS, a test for hepatitis - known as the hepatitis B-core antibody test - could be used to identify those at high risk for AIDS.

In other words, by using a laboratory test that detects the hepatitis B-core antibodies, blood banks and plasma centers could identify and exclude blood donors who also were at risk of having or developing AIDS.

"To some of us (at CDC), what should have been done was relatively clear," Evatt said. "We were recommending using the test."

While CDC officials could recommend it, they did not have the regulatory power to require the test. That authority belonged to the FDA. And there, officials turned to the industry for direction.

In December 1983, the Blood Products Advisory Committee met on the campus of the National Institutes of Health near Washington to debate the issue. During the long and sometimes heated session, it became apparent that even though the antibody test could identify donors at high risk for AIDS, not to mention hepatitis, many representatives from the blood industry objected to its use.

Because it was not a specific test for AIDS, they argued, its use would result in the exclusion of some safe donors and of many homosexual donors who had a history of hepatitis but not of AIDS. It was argued that in cities that depended heavily on gay blood donors, such as San Francisco and New York, use of the test could seriously reduce local supplies.

Another argument was that it would be too costly. In addition to an estimated $3 for the test itself, there would be added expenses to recruit new replacement donors, several blood-bank officials said.

Near the end of the meeting, Michael Rodell, a representative of the plasma industry, suggested that a task force be formed to further study using the antibody test. The advisory committee unanimously agreed with the suggestion, a transcript of the December hearing says.

It is notable that, at a meeting the evening before the Dec. 15 meeting, the plasma manufacturers decided to request that a task force be formed.

According to a memorandum prepared a few days later by an official of Cutter Biologicals Inc., the largest U.S.-based plasma manufacturer: "This proposal was one that had been agreed upon by all the fractionators (plasma manufacturers) the previous evening. The general thrust of the task force is to provide a delaying tactic. It was generally agreed that core testing would eventually become a requirement."

"I never heard of that (meeting)," said Dr. Dennis Donahue, who was director of the FDA's Division of Blood and Blood Products from 1980 to 1986 and played a key role in many of the agency's decisions.

Donahue was one of two non-industry members of the task force that was formed to study the hepatitis B-core antibody test. Six of the other nine members were from the plasma industry and three were from blood banks.

In May 1984, the task force issued its findings, saying it could not reach a consensus. Citing many of the same arguments made five months earlier, a majority of the task force opposed requiring the test. Three members, including Donahue, favored requiring it.

The minority position paper drafted by Donahue's group noted that AIDS cases were doubling every six months and that voluntary steps to exclude high-risk donors were not working in all cases.

"In the absence of a test for the presence of the causative agent of AIDS, the only means of reversing this trend is to more effectively identify plasma donors who are members of high-risk groups," the position paper argued.

Donahue said recently that while he believed his approach was logical, "The fact of the matter is, there are two sides to every argument."

The FDA accepted the view of the industry-dominated task force and did not require the test.

While the FDA declined to take action, some blood banks and plasma centers started to use the hepatitis antibody test on their own. The reasons: public pressure and competition. Among them was Cutter.

In the same memo that described the task force's delaying tactic, the Cutter official privately wrote his colleagues that "the anti-core testing would add a further measure of confidence in product safety at a relatively low cost for the products involved."

Even before the December 1983 meeting of the Blood Products Advisory Committee, Cutter officials began implementing the test at their collection sites.

"We recommend that the implementation of core testing be accelerated to the maximum degree possible to obtain a competitive advantage in the marketplace," says a Dec. 19, 1983, internal company memo. "We made no mention of our plans to the others."

By June 1984, three of the five largest blood banks in northern California were using the test, usually in response to pressure from patients, hospitals and doctors.

The FDA seemed to go to unusual lengths to downplay these developments. In April 1984, the agency released a statement reading in part:

"On the basis of the information available to date, it is possible that screening tests other than anti-core may ultimately prove to be more predictive and generally useful in improving the safety of blood and blood products. It would therefore be unwise to adopt anti-core testing to the exclusion of other screening tests."

In other words, until there's a better test, don't do anything.

In February 1986, the Blood Products Advisory Committee finally recommended using the hepatitis B-core antibody test - but only for screening out donors with a history of hepatitis.

The FDA accepted the recommendation. Even though the test is now used by almost all blood banks, the regulatory agency still does not legally require it and has no standards governing its use.

Read on to Part 3 - Fear of AIDS Spurs Change