Very Bad Blood

By James O. Jackson/Bonn

It began with simple arithmetic. German health officials tracing some unexplained cases of HIV infection examined the records of a small blood- supply company in Koblenz last month and noticed a startling discrepancy. UB Plasma had sold 7,000 units of blood since 1992 but had purchased only 2,500 kits to screen for HIV, the virus that causes AIDS. The conclusion: either the firm had failed to test thousands of units, or it had "pooled" units from multiple donors before conducting the tests, an illegal practice that reduces the chances of detecting HIV contamination.

Investigators discovered that after UB Plasma began running into financial trouble two years ago, technicians were told to pool units to save money on the $2 test kits. When the German manufacturer of the kits stopped deliveries because UB Plasma was not paying its bills, technicians switched to an unauthorized and even less reliable test. There was also chilling evidence that the firm may have distributed blood that was not screened at all.

When the extent of the violations became clear in October, the authorities moved quickly to shut down UB Plasma. They arrested the manager and three employees on charges of fraud and "negligent bodily harm." Last week they began tracing batches of company blood distributed to at least 88 hospitals and four companies in Germany and abroad. Three cases of HIV have been attributed to tainted blood, but a prominent pharmacologist, Ulrich Moebius, warned there may be more. "This," he said, "is only the tip of the iceberg."

The news of potential contamination of Germany's blood supply hit like a bombshell in a country already shocked by a decade-old scandal implicating negligent health officials in a cover-up of HIV-infected blood. The reports of HIV cases from UB Plasma blood raised fears among millions who had received transfusions over the past eight years. Hospitals were flooded with calls from former patients, and health administrators faced a rash of cancellations of elective surgery. "People aren't just afraid, they're panicking," said Erhard Seifried of the German Red Cross.

Health officials made valiant efforts to play down the threat of infection. "The absolute risk for the general population is extremely low," insisted Dr. Robert Zimmermann, head of the blood bank at Berlin's Rudolf Virchow Clinic. Dr. Elke Gossrau of the German Red Cross put the risk at about 1 in 1 million.

The official response did little to calm fears. Health Minister Horst Seehofer recommended that anybody who had received blood products since 1982 undergo a test for HIV -- which caused a run on testing sites. Hospitals were laboriously checking records to identify patients who received blood from UB Plasma, but the task was huge and the records were not always clear on the source of the products used.

German officials may be guilty of laxity in policing the blood industry, especially UB Plasma. From 1985 to 1989 the firm operated without a license by exploiting a loophole in the law permitting production of small batches of plasma with case-by-case approval. In 1987 a UB Plasma worker told government officials that the company was distributing questionable blood products. The company's recent poor financial condition went unnoticed by regulators.

The scare rapidly spread beyond Germany. UB Plasma records showed shipments went to Austria, Greece and Saudi Arabia, as well as to intermediary companies that may have sent the products to France, the Netherlands, Britain, Portugal, Sweden, Italy and Switzerland. U.S. armed forces stationed in Germany rely on their own blood sources, which have been screened for HIV. Officials said they do not purchase blood products locally.

The case raised doubts about the blood industry worldwide and the safety of supplies. In the U.S., American Red Cross spokesman Felix Perez insisted that the supply "is safer than it has ever been." But the industry has persistently failed to follow Food and Drug Administration standards for blood screening. FDA Commissioner David Kessler, in congressional testimony in July, accused suppliers of "not assuming adequate responsibility for putting in place and then following the basic quality-assurance programs and standard operating procedures required to assure the safety of the blood supply." Some critics argue that the German system is fundamentally flawed because it makes use of for-profit companies that may be tempted to take shortcuts such as buying blood from questionable donors or pooling blood for testing. A former UB Plasma employee alleged that drug-addict donors were accepted there. "Profits should not be allowed in the blood business," said Ellis Huber, head of Berlin's medical association. "The temptation to cheat is too great."

In the end, patients may have to resign themselves to putting their lives in the hands of an increasingly beleaguered health system. At the same time, they should insist that their politicians do a better job of policing an industry that is, literally, their life's blood.

With reporting by Nomi Morris/Berlin, Rhea Schoenthal/Bonn and Dick Thompson/Washington