Policing the Plasma Plants

Plasma, a clear, yellowish fluid that constitutes about 60% of human blood, is an important medical commodity. Hospitals use it for direct, life-saving transfusions to victims of burns and injuries, while pharmaceutical companies have been purchasing increasing quantities for use in the production of vaccines and serums. This growing demand has created a thriving business for hundreds of unlicensed private laboratories, which buy plasma for $5 and up per pint, sell it for at least a 100% profit. But it has also led to a serious public-health problem, and last week the National Academy of Sciences-National Research Council proposed strict new rules to police the plasma plants.

The prime target is the widespread use of plasmapheresis by commercial blood laboratories. An old technique, plasmapheresis separates the components of whole blood and returns the red blood cells--hardest for the body to replace--to the donor. The procedure as now employed can be both profitable and dangerous. Whole blood should not be given more often than every two months. But donors can and do sell plasma far more frequently, and often to laboratories that fail to protect either them or the ultimate user of their life-saving product.

Lack of Control. One of the dangers that blood donors face is serum hepatitis, a sometimes fatal liver disease transmitted by unsterile laboratory equipment. But the council is even more disturbed by the lack of adequate control over the majority of plasmapheresis programs now under way in the country. Coordination among programs is lacking, record keeping practically nonexistent.

Donors are both unscreened and untested. Though most whole-blood donors are volunteers in good health, many of the approximately 100,000 plasma donors are Skid Row bums and drug addicts. Desperate for money, they may involve themselves in several programs at once, selling plasma as often as three or four times a week. Many allow themselves to be hyperimmunized, so that their blood will produce disease-fighting antibodies. Others participate in programs that could create RH-factor incompatibilities, exposing them to illness or even death if they themselves should later require blood transfusions or certain types of medication.

Appalled by this situation, the Research Council has responded by drafting a set of guidelines aimed at protecting both the donor and the user of plasma products. To weed out the unfit, it proposes limiting participation in plasmapheresis programs to persons of "fixed address."

The council also wants to establish regional registries to identify qualified donors and to maintain records on them.

Such a system would also prevent donors from either giving plasma too often or taking part in programs involving the injection of incompatible antigens. It also proposes strict limitations on the laboratories themselves. Under the suggested rules, a physician would be required to supervise all laboratory blood operations, examine all donors.

More than guidelines, however, are needed to deal with the burgeoning blood business. The council itself has no enforcement authority, and the U.S. Public Health Service's Division of Biologics Standards can regulate only the purity and safety of those plasma products shipped across state lines. Washington can exercise only limited control over the purchase of raw plasma from unlicensed laboratories. It is up to the states to regulate the commercial blood centers, and few, so far, have shown any inclination to act.

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